requirements for environmental electronic data delivery
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The Association of Public Health Laboratories (APHL) is a national non-profit organization dedicated to working with members to strengthen governmental laboratories that perform testing of public health significance. By promoting effective programs and public policy, APHL strives to provide member labora-tories with the resources and infrastructure needed to protect the health of US residents and to prevent and control disease globally.
© Copyright 2012, Association of Public Health Laboratories. All Rights Reserved.
This publication was supported by Cooperative Agreement Number #U60HM000803 from the Centers for Disease Control
and Prevention (CDC). Its contents are solely the responsibility of the authors and do not necessarily represent the official
views of the CDC. This publication was also developed under Assistance Agreement No. 83483301 awarded by the U.S.
Environmental Protection Agency. It has not been formally reviewed by EPA. The views expressed in this document are solely
those of APHL, and EPA does not endorse any products or commercial services mentioned in this publication.
1.0 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
1.1 Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
1.2 Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
1.3 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
2.0 Overview of Reporting Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.1 Type 1t Electronic Delivery Requirements . . . . . . . . . . . . . . . . . . . . . . 12
3.0 Type 2 Data Submission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3.1 Type 2 Electronic Submission Requirements . . . . . . . . . . . . . . . . . . . . 15
3.2 Data Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.3 Electronic Delivery Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
4.0 Type Two Fact Sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Appendix A: Type 1t Data Submission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Appendix B: Comparison of Type 1t and Type 2 Required Data Elements . . . . 26
Appendix C: Data Exchange Template (DET) for Type 2 . . . . . . . . . . . . . . . . . . . 30
Specific Type 2 Data Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Data Element Value Formats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
The Measure Details Data Group and the Characteristics Details Data Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Example Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
DET Data Element Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
DET Valid Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Table of Contents
Appendix D: XML Reporting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
XML Syntax Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Type 2 Data Hierarchy for Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Type 2 DTD Required Data Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Appendix E: Type 2 Document Type Definition (DTD) . . . . . . . . . . . . . . . . . . . . . 49
List of Tables
Table 1. Summary of Submission Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Table 2. Type 1t Fact Sheet and Summary of Required Data Elements . . . . . . 13
Table 3. Type 2 Fact Sheet and Summary of Data Elements . . . . . . . . . . . . . . 17
Table 4. Type 1t Data Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Table 5. Data Group Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Table 6. Possible Measurements with the Measure Details Data Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Table 7. TYPE 2 DET Data Element Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Table 8. DET Valid Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Table 9. DTD Required Data Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Table 10. DTD Conditionally Required Data Groups . . . . . . . . . . . . . . . . . . . . . . 48
List of Figures
Figure 1 Relationship of LIMS, EDD, and Data Output Options . . . . . . . . . . . . . . .9
Figure 2 Type 2 DET Type 2 Data Group Organization . . . . . . . . . . . . . . . . . . . . 14
Requirements for Environmental Electronic Data Delivery Submissions 5
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1. Executive SummaryThis document fulfills several next steps identified in a January 2011 white paper, “Envi-ronmental Laboratory Electronic Data Management.”1 The audience includes laboratories, information technology (IT) support, laboratory information management systems (LIMS) vendors, data generators, and data consumers, since each have critical roles in electronic data delivery.
APHL proposes a granular-level environmental electronic data deliverable (EDD) with a stan-dardized, defined list of data elements and their associated data structures and components. This EDD is agnostic with regard to method, matrix, or governmental program.
Two EDD data deliverables and their associated data elements are defined. One is transitional, referred to as Type 1t which includes a limited set of data elements and is reported as a spread-sheet. The second includes an expanded set of data elements and is reported as an XML.
This document provides a narrative that describes the:
1. relationship of the collected laboratory data,
2. LIMS,
3. EDD, and
4. data output options.
Additionally, a set of detailed appendices are offered for IT developers that require detailed specifications to construct a data exchange template (DET).
In order to make this a true data standard, next steps include partnering with:
• federal agencies (i.e., EPA, CDC and FDA) on the use of a single, comprehensive data exchange template (DET) and document type definition (DTD), and
• LIMS vendors on a coordinated strategy to implement systems able to automatically support the capture and reporting of a standardized set of data elements as defined in the DET.
1 APHL . “Environmental Laboratory Electronic Data Management.” Available at: http://www.aphl.org/aphl programs/eh/Documents/EH_2010Dec_EDM_WhitePaper.pdf
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2. BackgroundEnvironmental health laboratories support many local, state, and federal programs, such as:
• emergency preparedness and response,
• human biomonitoring,
• food safety,
• radiation exposure assessment,
• drinking water quality,
• waste water treatment,
• solid waste testing, and
• environmental exposure assessment.
The data associated with these programs includes chemical, radiological, and microbiology measure-ments on environmental and clinical samples or specimens. Measurements occur across a wide range of matrices and environmental media as well as use various methods utilized by multiple programs.
In this age of increased electronic communication, it is common for data users to request data from laboratories in a standardized electronic format also known as an electronic data deliverable (EDD). Reporting EDDs saves laboratories time by sending data directly from a laboratory information manage-ment system (LIMS), minimizing and possibly eliminating manual data entry.
Additionally, EDDs reduce transcription errors and speed up data delivery. For the data user, EDDs save time by standardizing the data collected from multiple laboratories using multiple analyses. It also allows the use of automated data review software to approve and share data. EDDs minimize the need to har-monize and cleanse data.
Local, state and federal agencies possess different reporting requirements and systems, including unique EDDs with unique data elements and inter-relationships. The existence of multiple EDDs places a large burden on laboratories and reduces the overall ability of public laboratories to network and inte-grate information.
Even within agencies, there can also be multiple technical implementations of a data standard.2 Ulti-mately, support of multiple data deliverables may result in slower reactions to public health threats, possibly increasing morbidity and mortality.
The reporting and review of environmental data includes many complexities not typical of clinical data. These complexities contribute to the organic development of multiple data deliverables. For example, environmental data is often numerical (versus positive or negative), method-dependent, and sample- centric. Simple “results” are often not sufficient for reviewers who may wish to view a variety of raw quality control data associated with these results.
2 For example EPA uses: SCRIBE, eDWR, SDWIS, SEDD, ERLN et al.
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Requirements for Environmental Electronic Data Delivery Submissions 7
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In fact, data reviewers increasingly seek to use quality control data to provide accountabil-ity for the data set, a concept not addressed with certification. The quality control data is particularly important during multi-agency investigations where laboratories must network together and do not share a common certification requirement. Also, such data is important during emergency response when reviewers may need increased confidence in the data prior to making decisions or posting it for public consumption.
The Association of Public Health Laboratories’ (APHL) Environmental Health Committee, Environmental Laboratory Subcommittee, and Informatics Committee are working together to improve environmental LIMS implementation, data exchange, and interoperability.3 One of their goals was to propose a standard EDD with a defined list of data elements, comprehen-sive enough to support specific programmatic and data user needs.
APHL envisions laboratories able to provide an EDD that includes the following:
1. analytical method and assurance that the method was followed,
2. raw quality control data associated with the analytical sequence that defines target substance results,
3. unique laboratory analytical measurement or specifications necessary to evaluate the raw data,
4. an audit trail from laboratory data collection to client reporting, and
5. a standard electronic submission format.
By providing this information, data generators and consumers can review a data submission and know that all the data measurements submitted match what the results generated.
LIMS vendors are an important component of successful EDD implementations. LIMS ven-dors must be able to assure public laboratories that individual LIMS implementations can capture and output the necessary data elements needed to support multiple agency needs. The ability to exchange a defined set of data elements is an important step toward promoting environmental public health laboratory interoperability.
3 APHL. “Environmental Laboratory Electronic Data Management”. Available at: http://www.aphl.org/ aphlprograms/eh/Documents/EH_2010Dec_EDM_WhitePaper.pdf.
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3. IntroductionIn this requirements document, APHL proposes a granular-level environmental electronic data deliverable (EDD) with a standardized, defined list of data elements and their associated data structures and components.4 Over time, APHL hopes laboratories updating their laboratory information management system (LIMS) will use this EDD to create standardization at the federal, state and local levels. Similarly, as federal, state, and local agencies make changes to reporting requirements, APHL hopes that they will use the detailed specifications contained herein, thus creating data interoperability and increasing efficiency both for data reviewers and generators.
A standardized electronic data deliverable that is method-, matrix- and program-agnostic is consistent with the ability to meet multiple agency reporting needs. The scope of this docu-ment does not include the transport nor the vocabulary considerations associated with multiple agencies and programs. Instead, attention focuses on defining the data elements that support the collection of raw data from instruments and the associated data structures. Future work should standardize the terminology associated with these data elements across multiple agencies.
Figure 1 illustrates the relationship of the EDD to a LIMS and multiple electronic data output options. First, the LIMS should collect the raw and quality control data from the analytical instrument. From there, a standardized EDD allows data to be organized using a compre-hensive list of data elements and structures. Mapping software facilitates standardized EDD delivery to multiple data consumers, each with unique reporting requirements.
A standardized EDD also facilitates automated data review (ADR) associated with data validation. ADR can replace often-laborious manual review that assures that data are of known quality. Confidence in data quality is essential for the decision-making process, supporting regulatory enforcement, litigation, and policies regarding human health and safety.
4 This APHL requirements document is modeled after EPA’s draft “Requirements for Environmental Response Laboratory Network (Type 2) Data Submissions” for environmental public health laboratories to use in LIMS implementations. After reviewing multiple EDDs used to represent environmental data, APHL believes this particular model is the most modern and comprehensive. (www.epa.gov/erln)
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APHL’s goal is a universal EDD —one that can be used to support the varied data require-ments of multiple agencies such as EPA (including its multiple program offices), CDC, FDA, and others. The proposed EDD is: based on accepted standards, flexible and capable of meeting emerging standards. Components of this goal include:
• The EDD focuses on a set of discrete data elements and their relationship to each other—i.e., how they relate to the collection of analytical measurements (e.g. the analytical sequence). As an example, by collecting the time of a preparation step for each analyte and sample type, the reviewer can compare this time to sample login time and assure that preparation took place in a timely fashion.
• The EDD does not negate the ability of multiple agencies to receive data in their individual, unique reporting formats. Figure 1 (pictured above) illustrates that various reporting formats of electronic data messages can be tailored from the data elements.5 Standardization allows EDDs with fewer data elements to be easily mapped.
• The use of XML allows the creation of relationships between data elements.
• The EDD focuses on those data elements generated by the laboratory. While associated demographic and metadata is important, this data is very program-specific and does not lend itself to standardization. However, this data can be linked to the laboratory data via reference numbers. For example, many environmental agencies
5 Many relatively inexpensive third-party tools and data brokers can convert one message type to another, so long as the data elements exist in both messages.
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Figure 1 Relationship of LIMS, EDD, and Data Output Options
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manage metadata through a separate data delivery. This data is often referred to as “pass-through data.”
• The EDD comprehensively manages quality control data/measurement quality objectives (MQOs).6 Collection of quality control data allows results to be validated against measurement quality objectives and promotes accountability.
• A standardized EDD facilitates the use of automated data review (ADR) and validation. Many data consumers may not wish to see quality control data or MQOs, but appreciate knowing that the data was validated. An example is EPA’s WebEDR that provides a web service to upload and perform ADR review both within the laboratory and by a reviewer.
APHL believes that laboratories need two reporting formats at this time. The first represents a very simplified option, a spreadsheet labeled the Type 1t (where “t” stands for transition). The preferred XML Type 2 option includes relational data groups, additional measurement quality objectives, and added flexibility.
6 MQOs are defined as specified performance criteria used in a sampling and analysis plan and may include evaluation of quality control data for completeness, sequence, frequency, correctness, and limits. Fortunately, laboratories typically use a fairly universal approach to collect sample data and associated quality control data. The process for collecting this inclusive set of data is referred to as the “analytical sequence.” The more MQOs included in the review of the quality control data in an analytical sequence, the more complete the evaluation. This evaluation assures that the target results are well documented. By linking MQOs to target results for field samples, the data reviewer adds accountability to the data set. While certification and accreditation provide evidence of capability at some point in time, MQOs provide direct accountability to the actual data set. This accountability is particularly useful during surge or when standardized testing is provided with new variables.
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2.0 ovERvIEw of REPoRTIng REquIREmEnTS
Electronic data deliverable (EDD) formats include:
• an unformatted spreadsheet, where the column header defines the data for that column
• or eXtensible markup language (XML7).
The XML format best facilitates the import of data into project-level or enterprise-level rela-tional databases, as well as the processing of the data by automated electronic data review and assessment software. Data is structured and can be nested. It is one of the most popular languages used for communicating data among information systems, and because of this, a plethora of tools exist to assist in reading a file or the generation of a well-formed XML file from an in-house database. Many laboratory information management systems (LIMS) manu-facturers provide this functionality as part of their system. Many of the tools available on the market provide a mapping tool that allows a user to point and click to where data is located and map it using a Document Type Definition (DTD), generating a complete XML file based on this mapping. For these reasons, APHL recommends the XML format over the spreadsheet.
In order for XML files to remain useful as a common language among systems, certain rules regarding organizing information and syntax used must be followed. XML files must be vali-dated to ensure the file adheres to any business rules established for a program (validation), as well as to XML standards (syntax). Currently, there are two options for determining proper syntax and validation of an XML file: a Document Type Definition (DTD) or an XML Schema Definition (XSD). Currently, the DTD option is recommended; however, a future goal is to move to XSD.
Two types of data deliverables are provided in this document. Type 2 is the more robust data standard which utilizes XML formatting. APHL envisions that the Type 2 data deliverable will become the standard. Recognizing that many laboratories are developing electronic capabil-ity, a transition is offered that allows a spreadsheet and fewer MQOs. This optional EDD is labeled Type 1 “t” for transition. A Type 1t data deliverable can even be produced manually, an option for laboratories with LIMS implementations still in their infancy. Laboratories may use many off-the-shelf products to create their Type 1t submission.
In addition to format, the two EDD types also differ in content. The Type 1t data submission includes fewer data elements, while the Type 2 data submissions allow the data reviewer to reproduce the analytical sequence to an increased degree and to use the raw data to better evaluate MQOs. Table 1 summarizes the two EDDs.
7 XML (an open standard) provides a common way to describe electronic submission in order to transfer data between systems, databases, and organizations. XML files are hierarchical text-based files which consist of elements that describe a piece of data. XML is an accepted standard, it can be read by multiple machines and it has become a standard for business transactions.
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2.1 Type 1t Electronic Delivery RequirementsType 1t data must be reported electronically for every required data element (See Table 1). The following identifies the specific requirements for electronic reporting.
• Report in a computer-readable format: a spreadsheet.
• Ensure that the file contains a column representing the required data with the Type 1t data element names as column names (See Appendix A).
• A single substance for a sample will constitute a new row within the spreadsheet.
• Data must be present for all required fields.
• Several fields will be repeated in each row in order to ensure the project information can be identified for each substance when processing the data. As an example, every unique analyte must be reported in a new row, but the sampleID must be repeated for each row.
• A single spreadsheet should only contain results associated with the designated data reporting group.
• The spreadsheet must be void of any formatting such as text formatting as well as page formatting.
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Submission Type Purpose ScopeRequired Electronic
Format
Type 1tProvides a higher-level picture of the result information.
Result information for target and non-target substances of field and lab-generated samples
Spreadsheet
Type 2
Provides information in order to perform an automated assessment on field and laboratory-generated samples.
Type 1t plus substance information for each analysis performed on a field or laboratory-generated sample, including batch information, as well as some calibration information (optional)
XML
Table 1. Summary of Submission Types
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Table 2 provides a short summary of the data elements used in the Type 1t EDD. A complete listing is provided in Appendix A, designed for laboratory/IT personnel responsible for provid-ing environmental electronic data exchange.
Table 2. Type 1t Fact Sheet and Summary of Required Data Elements
Type 1t Examples of Required Data Elements*:
* Data must be provided for all Elements for each substance provided.
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Scope Result information for target and non-target substances of field and lab-generated samples
Electronic Format Spreadsheet
Hardcopy Portable Document File (PDF) required; paper upon request
Required Summary Forms
Organize measured results of the reported samples for each of the analytical methods utilized in the analytical testing
Instrument and Other Supporting Data Not Required
• SubstanceName
• SampleMatrix
• MethodIdentifier
• SampleIdentifier
• SampleCollectionEndDate
• AnalysisEndDate
• Result
• ResultUnits
• ReportingLimit
• ReportingLimitType
• ReportingLimitUnits
• AnalyticalServiceRequestIdentifier
• OrganizationIdentifier
• ProjectIdentifier
• DataPackageIdentifier
• SubstanceType
• SampleType
• AnalysisStartDate
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3.0 TyPE 2 DATA SuBmISSIon
3.0 TyPE 2 DATA SuBmISSIon
A Type 2 submission provides data users with the ability to perform an automated data assessment based on defined quality objectives. By requiring data to be submitted using eXtensible Markup Language (XML), a Type 2 EDD allows the establishment of the necessary relationships for data validation.
Type 2 focuses on arranging information into groupings that represent key components of the analytical process, allowing both the analytical process to be re-created during data review and for relationships to exist between the different data elements.
Data required from Type 1 is still required in Type 2, but data are now organized under ob-jects that define the relationships between the data. For example, “Sample Identifier” in Type 2 submissions is under the heading (data group) “SampleDetails” because it is descriptive information related to a sample. The use of this format also accommodates the reporting of additional data associated with sample characteristics (e.g., pH, temperature, % moisture, etc.); sample handling; sample preparation; laboratory batching; and sample analysis.
The following diagram depicts the data groups defined by the Type 2 Data Exchange Template (DET), how they relate to one another, and how they are organized for use by a Data Type Defi-nition (DTD). In order for submitted data to pass a validation test, laboratories must organize their XML submissions so that a data group retains the same relationships as the Type 2 DTD.
Figure 2: Type 2 Data Exchange Template and Group Organization
Organization Details Method Details
Point of Contact Details
Project Details
Sample Details
Analysis Details
Substance Identification Details
Characteristic Details
Sample Preparation Details
Measure Details
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3.0 TyPE 2 DATA SuBmISSIon
Type 2 formatting presents laboratories with the ability to provide a submission with (or with-out) calibration data. Type 2 data submissions include:
• laboratory & methods used;
• data associated with sample characteristics, sample handling, preparation, laboratory batching & sample analysis;
• data associated with the substance measured and sample type; and
• measurements associated with the expected result for non-target compounds.
Type 2 also offers the ability for laboratories to report a variety of optional data that a data user can request such as background information regarding the methods used, additional contact information or additional details pertaining to a sample.
Type 2 data elements provide information that allows for automated data review to assess precision, accuracy, sensitivity, selectivity, and representativeness.
3.1 Type 2 Electronic Submission RequirementsType 2 data shall include all of the elements included in Type 1t; however, additional elements can be included to enable the data user to perform a more extensive data assessment.
Results are reported for each analysis performed on a sample as well as laboratory-generat-ed positive and negative control samples (e.g., laboratory control samples [LCS], duplicates, blanks, etc.). Data are also reported for non-target substances (e.g., surrogates, internal standards, tentatively identified compounds, etc.) along with the results of the sample and laboratory batching information. EPA data users may request that calibration information be provided with a Type 2 submission, which will require the laboratory to provide additional information.
3.2 Data Requirements SummaryThe Type 2 Data Exchange Template (DET) defines the specific data elements applicable to each submission type:
• Field-generated samples
• Laboratory-generated (positive & negative control) samples, i.e. LCS, blanks, MS/MSD, etc.
• Target and non-target substances
• Batching information
• Instrument performance & general calibration information
• Tentatively identified compounds
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3.0 TyPE 2 DATA SuBmISSIon
3.3 Electronic Delivery RequirementsType 2 data must be reported using an XML file meeting DTD requirements:
• Report in a computer-readable format using an XML file.
• Ensure the XML includes the following as the 2nd line in the XML file: <!DOCTYPE ProjectDetails SYSTEM “TYPE 2_GENERAL_1.dtd”>.8
• Ensure that the XML includes the appropriate syntax.9
• Ensure that the XML passes DTD validation; for example, through use of automated data review software such as WebEDR.
8 See Appendix E: Type 2 Document Type Definition (DTD)9 See Appendix C: Data Exchange Template (DET) for Type 2.
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4.0 TyPE Two fACT SHEET
4.0 Type Two fact SheetTable 3: Type Two Fact Sheet and Summary of Data Elements
ScopeType 1t plus substance information for each analysis performed on a field or laboratory-generated sample, as well as any calibration sample (optional)
Electronic Delivery Extensible Markup Language (XML)
Data Report Delivery Portable Document File (PDF) required, paper upon request
Required Summary Forms Type 1t plus additional measurement quality indicator information
Instrument and Other Supporting Data Not Required
• ProjectDetails
• DataPackageIdentifier
• DateFormat
• LaboratoryNarrative
• LaboratoryQualifiers Definition
• ProjectIdentifier
• OrganizationDetails
• OrganizationIdentifier
• MethodDetails
• MethodIdentifier
• SampleDetails
• SampleIdentifier
• SampleChainofCustody Identifier
• SampleCollectionEnd Date
• SampleMatrix
• SampleType
• AnalysisDetails
• AnalysisBatchIdentifier
• AnalysisEndDate
• AnalysisStartDate
• AnalysisType
• InstrumentIdentifier
• LaboratoryAnalysis Identifier
• MethodIdentifier
• SubstanceIdentification Details
• ExclusionIndicator
• ReportingLimit
• ReportingLimitType
• ReportingLimitUnits
• Result
• ResultUnits
• SubstanceName
• SubstanceType
• RunBatchIdentifier
Required Data Elements for Type 2 EDD
The following comprehensive appendixes are provided for laboratory or information technol-ogy personnel responsible for providing environmental electronic data exchange. The reader is also advised of the downloadable file “ERLN_General_1.dtd” that is used for Type 2 data exchange.
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APPEnDIxES:
• Appendix A provides a detailed Data Exchange Template for Type 1t format.
• Appendix B provides a comparison of the differences in Type 1t and Type 2 required data elements.
• Appendix C provides a detailed Data Exchange Template for the Type 2 format.
• Appendix D provides a detailed XML reporting guide.
• Appendix E provides the Type 2 Document Type Definition. For convenience this DTD is also available online.
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APPEnDIx A
Appendix A: Type 1t Data SubmissionType 1t EDDs provide the ability to report the most basic results information for target sub-stances of field samples. In order to ensure that more laboratories can provide data electroni-cally, Type 1t submissions do not require eXtensible Markup Language (XML); rather, the data is provided as a spreadsheet. The data formatting remains simple, but Type 1t transitions to Type 2 by adding data on laboratory-generated quality control substances such as blanks, laboratory control samples, and spikes, etc.
Type 1t provides the foundation for Type 2 data submissions by including result information for laboratory-generated samples and non-target compounds. By providing this information, data users are able to view a broader picture of the data being submitted. Type 1t data shall include final result information for target and non-target substances of field-generated and laboratory-generated samples. Results from laboratory-generated positive and negative con-trol samples (e.g., LCS, blanks, etc.) should also be reported.
Type 1t data submissions shall include the information detailed in the following table for every target substance of a field-generated sample.
Definitions for the TableRequired Data Elements: Define the basis for information necessary to identify the project, electronic submission, and minimum information necessary for the data submission type. Re-quired data elements must contain a value and be reported at all times. Required is indicated in the table below by an “R.”
Conditionally-required Data Elements: Defines additional elements that are required should a certain condition exist in the data submission. Conditional elements are only required if the analytical methodology requires the use of the elements indicated as conditional. Condition-ally required is indicated by a “C.”
Optional Data Elements: Defines information that a data user may want to request, or a laboratory may want to provide, in addition to the required or conditionally-required elements for a submission type. Data elements identified as optional do not need to be reported unless requested by the data user. Optional is indicated by an “O.”
Note: Valid Values for several of the data elements share values used with the EPA Staged Electronic Data Deliverable (SEDD) http://www.epa.gov/fem/pdfs/sedd52_valid_values.pdf
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Requirements for Environmental Electronic Data Delivery Submissions 21
APPEnDIx A
Additional instructions for the submission of Type 1t:
• Format for the content of all data elements is string/text.
• All date fields must be reported according to EPA’s ISO-based Representation of Date and Time Data Standard, Standard No.: EX000013.1 (e.g., YYYY-MM-DD hh:mm:ss).
• All times MUST be based on a 24-hour clock. Time zones are not included in this data element.
• Data tags with an asterisk ( * ) will contain repetitive content. The information for these data tags should be repeated in every row.
• A single substance for a sample will constitute a new row within the spreadsheet.
• The spreadsheet must be void of any formatting that can be applied using off-the-shelf products such as text formatting (bold, italics, underline), column formatting (date, general, number, custom), page formatting, hidden columns or rows, additional column names, calculated field values, or referenced fields.
• The order of the columns is not important; however, the column headings must be exactly as listed in the Tag in Table 4.
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APPEnDIx A
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es/C
omm
ents
Usa
geFo
rmat
Agr
eem
entN
umbe
r*A
clie
nt-d
efine
d nu
mbe
r or i
dent
ifier
that
sp
ecifi
es th
e co
ntra
ct o
r agr
eem
ent u
nder
w
hich
the
labo
rato
ry a
naly
zes
the
sam
ples
.
Pro
vide
if a
con
tract
num
ber e
xist
s, if
not
, le
ave
blan
k.C
Alp
hanu
mer
ic
Ana
lysi
sSta
rtDat
eTh
e da
te (a
nd ti
me,
if re
quire
d) o
f ana
lysi
s of
a s
ampl
e al
iquo
t or s
tand
ard.
If a
naly
zed
over
a ra
nge
of d
ates
, thi
s is
the
star
t dat
e.
RY
YY
Y-M
M-D
D
hh:m
m:s
s
Ana
lysi
sEnd
Dat
e
The
date
(and
tim
e, if
requ
ired)
of t
he e
nd
of th
e an
alys
is p
erio
d, if
the
sam
ple
aliq
uot
or s
tand
ard
was
ana
lyze
d ov
er a
per
iod
of
time.
The
date
sho
uld
refle
ct th
e en
d of
the
anal
ysis
per
form
ed b
y an
inst
rum
ent;
it do
es n
ot re
late
to th
e tim
e in
whi
ch
an a
naly
st c
ompl
eted
thei
r rev
iew
of a
n an
alys
is.
RY
YY
Y-M
M-D
D
hh:m
m:s
s
Ana
lytic
alS
ervi
ce
Req
uest
Iden
tifier
*A
clie
nt-d
efine
d nu
mbe
r or i
dent
ifier
that
sp
ecifi
es th
e se
rvic
e re
ques
t.O
btai
n fro
m A
naly
tical
Ser
vice
Req
uest
er
(AS
R).
RA
lpha
num
eric
CA
SR
egis
tryN
umbe
rTh
e un
ique
num
ber a
ssig
ned
by C
hem
ical
A
bstra
cts
Ser
vice
(CA
S) t
o a
chem
ical
su
bsta
nce.
Pro
vide
whe
n th
e su
bsta
nce
has
a de
fined
C
AS
num
ber,
if no
t, le
ave
blan
k.C
Alp
hanu
mer
ic
Com
men
t
A fre
e-fo
rm c
omm
ent fi
eld.
Info
rmat
ion
rela
ting
to th
e da
ta o
n a
parti
cula
r “ro
w”-
e.
g. c
omm
ents
rela
ting
to th
e S
ampl
eTyp
e or
Sub
stan
ceTy
pe o
r Res
ult e
tc
O
Alp
hanu
mer
ic
Dat
aPac
kage
Iden
tifier
*A
labo
rato
ry-d
efine
d id
entifi
er fo
r thi
s da
ta
subm
issi
on p
acka
ge. T
his
iden
tifier
app
lies
to a
sin
gle
ED
D.
R
Alp
hanu
mer
ic
Exp
ecte
dRes
ult
The
expe
cted
fina
l res
ult o
f a s
ubst
ance
th
at h
as b
een
spik
ed in
to a
n al
iquo
t at a
ny
time
durin
g th
e an
alys
is p
roce
ss, o
r the
tru
e va
lue
of a
sub
stan
ce in
the
sam
ple
anal
yzed
.
Pro
vide
if s
pike
d su
bsta
nce
was
add
ed to
a
sam
ple
for a
naly
sis.
The
exp
ecte
d re
sult
is w
hat s
houl
d be
foun
d in
the
subs
tanc
e.
If th
e su
bsta
nce
was
not
spi
ked,
leav
e bl
ank.
CA
lpha
num
eric
Exp
ecte
dRes
ultU
nits
Uni
ts a
ssoc
iate
d w
ith e
xpec
ted
resu
lt.P
rovi
de if
repo
rting
exp
ecte
d re
sult,
if n
ot,
leav
e bl
ank.
CA
lpha
num
eric
Tabl
e 4:
Typ
e 1t
Dat
a R
equi
rem
ents
X
Requirements for Environmental Electronic Data Delivery Submissions 23
APPEnDIx A
Dat
a Ex
chan
ge
Tem
plat
e (D
ET) T
agDefinitio
nB
usin
ess
Rul
es/C
omm
ents
Usa
geFo
rmat
Labo
rato
ryR
esul
t Q
ualifi
er
A la
bora
tory
-ass
igne
d st
ring
of re
sult
qual
ifier
s (u
sual
ly a
sin
gle
char
acte
r for
ea
ch q
ualifi
er),
base
d on
clie
nt-d
efine
d ru
les
and
valu
es. S
imila
r to
“inte
rpre
tatio
n”
used
in c
linic
al s
ubm
issi
ons
In o
rder
to s
tay
cons
iste
nt fr
om o
ne
subm
issi
on to
ano
ther
, the
onl
y qu
alifi
ers
that
will
be
used
are
“U”,
“J”,
and
“UJ”
.10R
Alp
hanu
mer
ic
Labo
rato
ryS
ampl
e Id
entifi
er
A la
bora
tory
-defi
ned
iden
tifier
for a
sam
ple
that
uni
quel
y id
entifi
es a
sin
gle
sam
ple
that
is
sub
ject
ed to
an
anal
ysis
.
OA
lpha
num
eric
Labo
rato
ryS
ubst
ance
Id
entifi
erA
labo
rato
ry-d
efine
d id
entifi
er fo
r a
subs
tanc
e.
OA
lpha
num
eric
Loca
tionI
dent
ifier
A cl
ient
-defi
ned
iden
tifier
of t
he s
ampl
ing
loca
tion
at a
par
ticul
ar s
ite.
O
Alp
hanu
mer
ic
Met
hod/
Iden
tifier
The
iden
tifica
tion
num
ber a
ssig
ned
by th
e m
etho
d pu
blis
her.
Obt
ain
from
AS
R.
RA
lpha
num
eric
Org
aniz
atio
nIde
ntifi
er*
A de
sign
ator
use
d to
uni
quel
y id
entif
y a
uniq
ue b
usin
ess
esta
blis
hmen
t with
in a
co
ntex
t.
Obt
ain
from
AS
R. I
f one
is n
ot p
rovi
ded,
th
e la
bora
tory
sha
ll in
clud
e an
iden
tifier
for
thei
r nam
e.R
Alp
hanu
mer
ic
Org
aniz
atio
nNam
e*D
escr
iptiv
e na
me
for t
he la
bora
tory
pe
rform
ing
this
ana
lysi
s.
OA
lpha
num
eric
Pre
para
tionE
ndD
ate
Dat
e an
d tim
e of
sam
ple
prep
arat
ion.
P
repa
ratio
n is
use
d ge
nera
lly to
incl
ude
met
hod
spec
ific
tech
niqu
es s
uch
as
extra
ctio
n, d
iges
tion,
and
sep
arat
ion.
If
prep
ared
ove
r a ra
nge
of d
ates
, thi
s is
the
star
t dat
e.
Pro
vide
end
dat
e an
d tim
e in
YY
YY-
MM
-D
D h
h:m
m:s
s fo
rmat
if a
pre
para
tion
was
pe
rform
ed o
n th
e sa
mpl
e. If
a p
repa
ratio
n w
as p
erfo
rmed
the
star
t and
end
dat
e m
ust b
e pr
ovid
ed, i
f not
, lea
ve b
lank
.
CYY
YY-M
M-D
D
hh:m
m:s
s
Pre
para
tionS
tartD
ate
The
date
and
tim
e of
the
prep
arat
ion
of
this
sam
ple
aliq
uot.
Pre
para
tion
is u
sed
gene
rally
to in
clud
e m
etho
d sp
ecifi
c te
chni
ques
suc
h as
ext
ract
ion,
dig
estio
n,
and
sepa
ratio
n. If
pre
pare
d ov
er a
rang
e of
da
tes,
this
is th
e st
art d
ate.
Pro
vide
sta
rt da
te a
nd ti
me
in Y
YY
Y-M
M-
DD
hh:
mm
:ss
form
at if
a p
repa
ratio
n w
as
perfo
rmed
on
the
sam
ple.
If a
pre
para
tion
was
per
form
ed th
e st
art a
nd e
nd d
ate
mus
t be
prov
ided
, if n
ot, l
eave
bla
nk.
CYY
YY-M
M-D
D
hh:m
m:s
s
10 “
U” in
dica
tes
that
the
subs
tanc
e w
as a
naly
zed
for,
but n
ot d
etec
ted.
“J”
indi
cate
s an
est
imat
ed v
alue
. The
“J”
qual
ifier
is u
sed
whe
n a
QC
para
met
er in
dica
tes
that
the
repo
rted
qua
ntity
cou
ld b
e in
accu
rate
, or w
hen
the
data
indi
cate
s th
e pr
esen
ce o
f a s
ubst
ance
that
mee
ts th
e id
entifi
catio
n cr
iteria
, but
the
resu
lt is
less
than
the
sam
ple
quan
titat
ion
limit,
but
gre
ater
than
zer
o. T
he “
UJ”
qual
ifier
indi
cate
s th
at th
e su
bsta
nce
was
ana
lyze
d fo
r, bu
t not
det
ecte
d, a
nd a
QC
para
met
er in
dica
ted
that
the
repo
rtin
g lim
it co
uld
be in
accu
rate
.
24 association of Public Health Laboratories
X X
24 association of Public Health Laboratories
APPEnDIx A
Dat
a Ex
chan
ge
Tem
plat
e (D
ET) T
agDefinitio
nB
usin
ess
Rul
es/C
omm
ents
Usa
geFo
rmat
Pro
ject
Iden
tifier
*A
desi
gnat
or u
sed
to u
niqu
ely
iden
tify
the
proj
ect t
o or
gani
zatio
ns s
harin
g da
ta.
R
Alp
hanu
mer
ic
Rep
ortin
gLim
itTh
e nu
mbe
r or v
alue
bel
ow w
hich
dat
a is
ty
pica
lly re
porte
d as
‘not
det
ecte
d’ fo
r the
su
bsta
nce
bein
g m
easu
red.
R
Alp
hanu
mer
ic
Rep
ortin
gLim
itTyp
e
One
of a
list
of c
lient
, reg
ulat
ion,
or
orga
niza
tion-
defin
ed a
cron
yms
or s
tatis
tical
m
etho
dolo
gies
that
spe
cify
the
type
of
repo
rting
lim
it.
R
Alp
hanu
mer
ic
Rep
ortin
g Li
mitU
nits
Uni
ts a
ssoc
iate
d w
ith re
porti
ng li
mit
as
dete
rmin
ed b
y th
e la
bora
tory
.
RA
lpha
num
eric
Res
ult
The
repo
rtabl
e m
easu
re o
f the
resu
lt fo
r th
e ch
emic
al, m
icro
biol
ogic
al, o
r oth
er
char
acte
ristic
bei
ng a
naly
zed.
RA
lpha
num
eric
Res
ult B
asis
The
basi
s up
on w
hich
the
final
resu
lts w
ere
calc
ulat
ed.
Pro
vide
the
resu
lt ba
sis
if th
e re
sult
has
been
mod
ified
to a
ccou
nt fo
r a s
ampl
e ch
arac
teris
tic s
uch
as %
moi
stur
e, %
so
lids.
Use
the
SE
DD
Val
id V
alue
s fo
r “R
esul
tBas
is” t
o de
term
ine
an a
ppro
pria
te
valu
e fo
r thi
s el
emen
t.”
CA
lpha
num
eric
Res
ultU
ncer
tain
ty
A va
lue
or s
et o
f val
ues
that
cha
ract
eriz
es
the
disp
ersi
on o
f the
val
ues
that
cou
ld
reas
onab
ly b
e at
tribu
ted
to th
e m
easu
red
resu
lt va
lue.
For R
adio
chem
ical
Ana
lysi
s on
ly a
t thi
s tim
e. E
nsur
e th
at U
ncer
tain
ty is
exp
ress
ed
in s
ame
Res
ult U
nit a
s th
e R
esul
t. If
ther
e is
no
unce
rtain
ty, l
eave
bla
nk.
CN
umer
ic
Res
ultU
nits
The
code
that
repr
esen
ts th
e un
it fo
r m
easu
ring
the
item
.
RA
lpha
num
eric
Sam
pleC
olle
ctio
nSta
rt D
ate
Dat
e an
d tim
e th
e sa
mpl
e w
as c
olle
cted
. If
colle
cted
ove
r a ra
nge
of d
ates
, thi
s is
the
star
t dat
e.
For l
abor
ator
y-ge
nera
ted
QC
sam
ples
not
as
soci
ated
with
a fi
eld
sam
ple,
ent
er th
e en
d da
te/ti
me
QC
sam
ples
wer
e pr
epar
ed
by th
e la
bora
tory
.
OYY
YY-M
M-D
D
hh:m
m:s
s
Sam
pleC
olle
ctio
nEnd
D
ate
The
endi
ng d
ate
that
a fi
eld
activ
ity w
as
finis
hed.
Ent
er s
tart
date
for g
rab
sam
ples
.R
YYYY
-MM
-DD
hh
:mm
:ss
X
Requirements for Environmental Electronic Data Delivery Submissions 25
APPEnDIx A
Dat
a Ex
chan
ge
Tem
plat
e (D
ET) T
agDefinitio
nB
usin
ess
Rul
es/C
omm
ents
Usa
geFo
rmat
Sam
pleI
dent
ifier
A de
sign
ator
use
d to
uni
quel
y id
entif
y a
sam
ple
with
in a
con
text
.
Obt
ain
from
Cha
in o
f Cus
tody
. If r
epor
ting
a la
bora
tory
-gen
erat
ed s
ampl
e, p
rovi
de
the
labo
rato
ry s
ampl
e id
entifi
er a
s th
e S
ampl
eIde
ntifi
er.
RA
lpha
num
eric
Sam
pleM
atrix
Sub
-med
ium
or m
atrix
that
is s
ampl
ed.
Obt
ain
from
Cha
in o
f Cus
tody
. If r
epor
ting
a la
bora
tory
-gen
erat
ed s
ampl
e, p
rovi
de
the
mat
rix o
f the
app
ropr
iate
fiel
d sa
mpl
e.R
Alp
hanu
mer
ic
Sam
pleT
ype
The
clie
nt-d
efine
d te
rm u
sed
to d
efine
the
spec
ific
type
of s
ampl
e be
ing
anal
yzed
. E
xam
ples
incl
ude:
Fie
ld_S
ampl
e an
d Q
C
sam
ples
suc
h as
: Mat
rixS
pike
, Mat
rix_
Spi
ke_D
uplic
ate
Labo
rato
ry_C
ontro
l_S
ampl
e.
Use
the
SE
DD
Val
id V
alue
s lis
t for
“Q
CTy
pe” t
o de
term
ine
an a
ppro
pria
te
valu
e fo
r thi
s el
emen
t.R
Alp
hanu
mer
ic
Sub
stan
ceN
ame
The
nam
e as
sign
ed to
a c
hem
ical
, bi
olog
ical
, or r
adio
logi
cal s
ubst
ance
or
feat
ure
that
des
crib
es it
in te
rms
of
its m
olec
ular
com
posi
tion,
taxo
nom
ic
nom
encl
atur
e, o
r oth
er c
hara
cter
istic
.
Use
the
SE
DD
Val
id V
alue
s in
stru
ctio
ns fo
r “A
naly
te n
ame”
and
“A
naly
teN
ameC
onte
xt” t
o de
term
ine
an
appr
opria
te v
alue
for t
his
elem
ent.
Ref
er
to th
e ap
prop
riate
offi
cial
pub
licat
ion
for a
lis
t of a
naly
te n
ame
valid
val
ues.
App
rove
d an
alyt
e na
me
lists
are
pro
vide
d by
: • T
he C
hem
ical
Abs
tract
s S
ervi
ce (C
AS
) no
men
clat
ure,
bas
ed o
n th
e 9t
h C
olle
ctiv
e In
dex
rule
s • T
he In
tern
atio
nal U
nion
of P
ure
and
App
lied
Che
mis
try
• The
Env
ironm
enta
l Pro
tect
ion
Age
ncy’
s (E
PA’s
) Sub
stan
ce R
egis
try S
yste
m (w
ww
.ep
a.go
v/sr
s/).
RA
lpha
num
eric
Sub
stan
ceTy
peA
clie
nt-d
efine
d id
entifi
er th
at id
entifi
es
the
type
of s
ubst
ance
repo
rted,
e.g
. Ta
rget
,Sur
roga
te.
Use
the
SE
DD
Val
id V
alue
s lis
t for
“A
naly
teTy
pe” t
o de
term
ine
an a
ppro
pria
te
valu
e fo
r thi
s el
emen
t.R
Alp
hanu
mer
ic
* Re
peat
dat
a fo
r eac
h ro
w in
clud
ed in
the
elec
troni
c su
bmis
sion
.
26 association of Public Health Laboratories
X X
26 association of Public Health Laboratories
APPENDIX B
Appendix B: Comparison of Type 1t and Type 2 Required Data Elements
Definitions for the TableRequired Data Elements: Define the basis for information necessary to identify the project, electronic submission, and minimum information necessary for the data submission type. Required data elements must contain a value and be reported in the data submission at all times. Required is indicated by an “R” in the DET. Data cannot be considered acceptable if required data is missing.
Conditionally-required Data Elements: Defines additional elements that are required should a certain condition exist in the data submission. Conditional elements are only required if the analytical methodology used requires the use of the elements indicated as conditional. Conditionally-required is indicated by a “C” in the DET.
Optional Data Elements: Defines information that a data user may want to request, or a labo-ratory may want to provide, in addition to the required or conditionally-required elements for a submission type. Data elements identified as optional do not need to be reported, unless requested by the data user. Optional is indicated by an “O” in the Type 2 DET.
Not Required Data Elements: Defines information that an EPA data user will not use and are not necessary for automated processing. This listing illustrates the simplicity of the Type 1t data submission compared to the Type 2. Data elements identified as not required cannot be electronically reported. Not required is indicated by a “-” in the DET.
TYPE 2 Data Group TYPE 2 Data Element Usage in Type 1t
Usage in Type 2
ProjectDetails AgreementModificationDescription - O
ProjectDetails AgreementModificationIdentifier - O
ProjectDetails AgreementNumber O O
ProjectDetails AnalyticalServiceRequestIdentifier R R
ProjectDetails Comment O O
ProjectDetails DataPackageIdentifier R R
ProjectDetails DataPackageName - O
ProjectDetails DataPackageVersion - O
ProjectDetails DateFormat - R
ProjectDetails LaboratoryNarrative - R
ProjectDetails LaboratoryQualifiersDefinition - R
ProjectDetails LaboratoryReportedDate - O
ProjectDetails ProjectIdentifier R R
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Requirements for Environmental Electronic Data Delivery Submissions 27
APPENDIX B
TYPE 2 Data Group TYPE 2 Data Element Usage in Type 1t
Usage in Type 2
ProjectDetails ProjectName - O
OrganizationDetails Comment - O
OrganizationDetails OrganizationIdentifier R R
OrganizationDetails OrganizationLocationAddress - O
OrganizationDetails OrganizationLocationAddressCity - O
OrganizationDetails OrganizationLocationAddressCountry - O
OrganizationDetails OrganizationLocationAddressState - O
OrganizationDetails OrganizationLocationAddressZipCode - O
OrganizationDetails OrganizationMailingAddress - O
OrganizationDetails OrganizationName O O
OrganizationDetails OrganizationTelephoneNumber - O
OrganizationDetails OrganizationType - O
PointofContactDetails Comment - O
PointofContactDetails ContactElectronicAddress - O
PointofContactDetails ContactFullName - O
PointofContactDetails ContactIdentifier - O
PointofContactDetails ContactTitle - O
PointofContactDetails ContactType - O
SampleDetails ContactIdentifier - O
SampleDetails LaboratoryReceiptDate - O
SampleDetails LaboratorySampleIdentifier O O
SampleDetails LocationIdentifier O O
SampleDetails Preservative - C
SampleDetails SampleChainofCustodyIdentifier - R
SampleDetails SampleCollectionEndDate R R
SampleDetails SampleCollectionStartDate O O
SampleDetails SampleIdentifier R R
SampleDetails SampleMatrix R R
SampleDetails SampleType R R
SampleDetails StorageBatchIdentifier - C
AnalysisDetails AnalysisBatchIdentifier - R
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APPENDIX B
TYPE 2 Data Group TYPE 2 Data Element Usage in Type 1t
Usage in Type 2
AnalysisDetails AnalysisEndDate R R
AnalysisDetails AnalysisStartDate R R
AnalysisDetails AnalysisType - R
AnalysisDetails Comment O O
AnalysisDetails ContactIdentifier - O
AnalysisDetails InstrumentIdentifier - R
AnalysisDetails LaboratoryAnalysisIdentifier - R
AnalysisDetails LaboratoryFileIdentifier - O
AnalysisDetails MethodIdentifier R R
AnalysisDetails PreparationBatchIdentifier - C
AnalysisDetails ResultBasis O O
AnalysisDetails RunBatchIdentifier - R
SamplePreparationDetails CleanupBatchIdentifier - C
SamplePreparationDetails CleanupType - C
SamplePreparationDetails ContactIdentifier - O
SamplePreparationDetails MethodIdentifier - O
SamplePreparationDetails PreparationEndDate C C
SamplePreparationDetails PreparationStartDate C C
SamplePreparationDetails SampleDataGroupType - C
SubstanceIdentificationDetails CASRegistryNumber C C
SubstanceIdentificationDetails ExclusionIndicator - R
SubstanceIdentificationDetails ExpectedResult C C
SubstanceIdentificationDetails ExpectedResultUnits C C
SubstanceIdentificationDetails LaboratoryResultQualifier C C
SubstanceIdentificationDetails LaboratorySubstanceIdentifier O O
SubstanceIdentificationDetails ReportingLimit R R
SubstanceIdentificationDetails ReportingLimitType R R
SubstanceIdentificationDetails ReportingLimitUnits R R
SubstanceIdentificationDetails Result R R
SubstanceIdentificationDetails ResultBasis O O
SubstanceIdentificationDetails ResultUncertainty O O
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Requirements for Environmental Electronic Data Delivery Submissions 29
APPENDIX B
TYPE 2 Data Group TYPE 2 Data Element Usage in Type 1t
Usage in Type 2
SubstanceIdentificationDetails ResultUnits R R
SubstanceIdentificationDetails SubstanceName R R
SubstanceIdentificationDetails SubstanceType R R
CharacteristicDetails CharacteristicName - C
CharacteristicDetails CharacteristicType - C
CharacteristicDetails CharacteristicUnits - C
CharacteristicDetails CharacteristicValue - C
CharacteristicDetails Comment - O
MethodDetails Comment - O
MethodDetails MethodCategory - O
MethodDetails MethodCodeType - O
MethodDetails MethodDescription - O
MethodDetails MethodIdentifier - R
MethodDetails MethodLevel - O
MethodDetails MethodModificationDescription - O
MethodDetails MethodModificationIdentifier - O
MethodDetails MethodName - O
MethodDetails MethodSourceName - O
MethodDetails MethodType - O
MethodDetails MethodVersion - O
MeasureDetails MeasureName - C
MeasureDetails MeasureQualifierCode - C
MeasureDetails MeasureUnitCode - C
MeasureDetails MeasureValue - C
Total Required: 18 29
Total Conditionally Required: 6 22
Total Optional: 9 48
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30 association of Public Health Laboratories
APPENDIX CAPPEnDIx C
Appendix C: Data Exchange Template (DET) for Type 2A Data Exchange Template (DET) comprises a standardized format that identifies the types of information required or allowed in a particular document or data exchange. Data exchange tem-plates contain no data, but rather define the format for exchange (according to data standards and trading partner agreements). Type 1t data has no relational concepts and so it has no DET.
Information included in this DET represents several different types of data necessary to even-tually recreate the analytical process of the laboratory. This includes information to indicate:
• what laboratory and instrument quality control samples are associated with field-generated samples (Batching),
• what analyses were used to come to a final result (Analysis grouping), and
• those substances that are the combination of other substances (Substance grouping).
This information ensures that data is put in the appropriate context and provides data users with a complete understanding of how the information was derived.
Data GroupsThe Type 2 DET categorizes like data together, identifying similarities, and then summarizing this information so that one data element could be used to represent multiple options. This solves a significant problem associated with using Document Type Definitions (DTDs) as a validation method: DTDs are limiting when additions or modifications need to be made to the data elements required by a reviewer. For example, if a new data element needs to be added, an update to the DTD would be necessary and laboratories would then need to change their methods for generating an eXtensible Markup Language (XML) document. By providing a ge-neric “data group” for these similar data elements (“MeasureDetails”), values can be added without impacting the DTD or a laboratory’s setup for generation of XML files.
The Type 2 DET contains several categories of data that require frequent modifications over time. For example, there is a seemingly endless list of what can be considered measures (which comprise a major component of any data associated with an analytical process) but there is a limited list of what a data user would need to know about a measure. In other pub-lished exchange models, measurements are individual data elements in the model.
In the Type 2 DET, measures are reported as a data group and an individual measure is reported as a value in the group. An example of this is ‘Amount Added’ which would be the value for the MeasureName data element (instead of the data element itself) and units would be a value of the MeasureUnitCode data element in the MeasureDetails data group. This concept allows for the expansion of the data standard without disrupting the existing process for providing and validating data.
This concept applies to several groups in the DET, including the MeasureDetails and Charac-teristicDetails data groups. The groups should be repeated under their appropriate primary group whenever a different measure or characteristic is called for.
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Requirements for Environmental Electronic Data Delivery Submissions 31
APPENDIX C
Relational GroupsAnother concept applied to the DET is a relational approach to reporting data using DTDs. Typically, data can only be reported as a hierarchy when validating against a DTD, which is why the future Type 2 hopes to use XML schemas for validation. In order to introduce this con-cept with the current Type 2 standard, the OrganizationDetails, PointOfContactDetails, and MethodDetails group are implemented as relational groups11.
To eliminate the need to report data in multiple places, the Type 2 relational group does not need to be included as a sub-group under a primary group. Instead, a data element exists within a data group that provides information in order for automated systems to establish a relationship between the data group that the element is reported in and a related data group. A ‘relational’ relationship provides the ability to reference another data group by providing some form of an identifier.
Specific Type 2 Data GroupsA “data group” defines what type of information is being reported in the group. The following are the Type 2 DET data groups along with their associated descriptions.
Table 5. Data Group Definitions
Data Group Name Definition
ProjectDetails Describes the format and content unique to a specific electronic data submission as it relates to a specific project.
OrganizationDetails Describes the unique framework of authority within which a person or persons act, or are designated to act, towards some purpose.
PointOfContactDetails Describes the particular terms regularly connected with a person so that you can recognize, refer to, or address him or her.
SampleDetails Describes one sample analyzed under the criteria established for the project.
SampleHandlingDetails Describes any manipulation of the sample (e.g., leaching, filtering, and ashing) prior to taking a sample aliquot for analysis.
AnalysisDetails Describes one complete sequence of events, from taking a sample aliquot through the measurement process, as defined as part of one method.
SamplePreparationDetails Describes a preparation or cleanup process as part of an analysis.
SubstanceIdentificationDetails Describes the substance level data from one analysis or one group of analyses.
InstrumentResponseDetails Identifies and reports the actual measurement data related to the analysis of substance peaks.
InstrumentResponseAdditional Details
A group of data elements that identifies cross-peak comparisons, multiple exposure readings, or data related to the comparison of two or more substances, such as those data elements that describe the effects of potentially-interfering substances on a peak.
11 DTD, or Document Type Definition, and XML Schema, which is also known as XSD, are two ways of describ-ing the structure and content of an XML document. In summary, schemas are a richer and more powerful of describing information than what is possible with DTDs.
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APPENDIX C
Data Group Name Definition
CharacteristicDetails Identifies and quantifies the intrinsic characteristics associated with a sample as received by a laboratory, or after the sample has been processed through a handling or preparation method.
MethodDetails Describes the procedures and techniques required to determine the methods used to obtain a result.
MeasureDetails Identifies the value and the associated units of measure for measuring an observation or analytical result value.
DataQualityIndicatorDetails Describes the quantitative and qualitative descriptors that are used to interpret the degree of acceptability or utility of data to the user.
Data Element Value FormatsThere are five types of data that can be used for a data element:
• Boolean: Allows only one of two values; true and false (Y or N).
• Date: The date format established is YYYY-MM-DD hh:mm:ss which is based on ISO 8601:2004. The technical representation of this date is YYYY-MM-DDThh:mm:ss where ‘T’ represents a space.
• Limited List: Defines a restricted list of values for a particular data element. Valid values are typically provided by the requester.
• Numeric: Allows for integer, decimal, or exponential formats for reporting numeric data.
• Text: Allows any value and format to be entered for a data element; this includes numeric values.
The “MeasureDetails” Data Group and the “CharacteristicsDetails” Data GroupOne problem with traditional fixed data element DETs is that there is little allowance for a new data element to be used without publishing a new DET. There are many examples of data elements that may be useful for a particular project on a one-time basis.
Laboratories need a way to allow optional or occasionally-needed data elements to be avail-able without having to publish a new DET. One way to “solve” this concern is to provide a “MeasureDetails” data group and a “CharacteristicsDetails” data group. These data groups allow new measurements to be collected and reported “on-the-fly”. Table 6 provides some examples of analytical measurement data elements that might be useful in a particular proj-ect. Also provided is a list of some examples of sample characteristics that might be useful to describe a sample. These lists of optional data elements can be very large, and many may never be used by a laboratory.
This flexibility of these two data groups allows new measurement values to be collected with-out the need to create a new DTD. The following list is a list of examples of optional measure names that a laboratory may provide and suggestions regarding data groups for which the
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Requirements for Environmental Electronic Data Delivery Submissions 33
APPENDIX C
measurements may be used. Each of the measures listed here can have additional attributes such as units and value which should be reported using the data elements available in the MeasureDetails data group. For example AmountAdded would be reported by populating the MeasureName data element with “Added Amount” and the MeasureValue data element with the actual value. There is no limit to the number of measure names that can be used. The Mea-sureName data elements can have any name that the service requestor and service provider agree upon.
Table 6. Examples of Possible Measurements that the MeasureDetails Data Group Can Handle
MeasureName Applicable Data Groups
AddedAmount SubstanceIdentificationDetails
AliquotAmount AnalysisDetails, SamplePreparationDetails
AnalysisDurationAnalysisDetails, SubstanceIdentificationDetails, InstrumentResponseDetails, InstrumentResponseAdditionalDetails
AnalyzedAmount AnalysisDetails
BiasErrorRatio SubstanceIdentificationDetails, InstrumentResponseDetails
CalibrationFactor SubstanceIdentificationDetails, InstrumentResponseDetails
CorrectionFactor AnalysisDetails, SamplePreparationDetails
CorrelationCoefficient SubstanceIdentificationDetails, InstrumentResponseDetails
CountingError SubstanceIdentificationDetails, InstrumentResponseDetails
Counts AnalysisDetails, InstrumentResponseDetails
DilutionFactor AnalysisDetails
Drift AnalysisDetails, InstrumentResponseDetails
EfficiencySamplePreparationDetails, AnalysisDetails, SubstanceIdentificationDetails, InstrumentResponseDetails
Energy InstrumentResponseDetails, InstrumentResponseAdditionalDetails
FilterSizeSampleDetails, SampleHandlingDetails, SamplePreparationDetails, AnalysisDetails
FinalAmount SamplePreparationDetails, AnalysisDetails
FlowRate AnalysisDetails
Frequency InstrumentResponseDetails, InstrumentResponseAdditionalDetails
Gradient AnalysisDetails
HandlingDuration SampleHandlingDetails
InitialAmount SampleHandlingDetails, SamplePreparationDetails
InjectionVolume AnalysisDetails
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APPENDIX C
MeasureName Applicable Data Groups
MeanRelativeResponseFactorSubstanceIdentificationDetails, InstrumentResponseDetails, InstrumentResponseAdditionalDetails
MeanRetentionTime SubstanceIdentificationDetails, InstrumentResponseDetails
NumberOfDilutions AnalysisDetails
PeakRatio InstrumentResponseDetails, InstrumentResponseAdditionalDetails
PercentDifferenceSubstanceIdentificationDetails, InstrumentResponseDetails, InstrumentResponseAdditionalDetails
PercentRecovery SubstanceIdentificationDetails, InstrumentResponseDetails
PercentRelativeStandardDeviationSubstanceIdentificationDetails, InstrumentResponseDetails, InstrumentResponseAdditionalDetails
Quench AnalysisDetails
RelativeResponse SubstanceIdentificationDetails
RelativeResponseFactorSubstanceIdentificationDetails, InstrumentResponseDetails, InstrumentResponseAdditionalDetails
RelativeRetentionTimeSubstanceIdentificationDetails, InstrumentResponseDetails, InstrumentResponseAdditionalDetails
RelativePercentDifferenceSubstanceIdentificationDetails, InstrumentResponseDetails, InstrumentResponseAdditionalDetails
RelativeRetentionTime InstrumentResponseDetails
ResolutionAnalysisDetails, SubstanceIdentificationDetails, InstrumentResponseDetails, InstrumentResponseAdditionalDetails
ResponseSubstanceIdentificationDetails, InstrumentResponseDetails, InstrumentResponseAdditionalDetails
RetentionTime SubstanceIdentificationDetails, InstrumentResponseDetails
SampleAmountSampleDetails, SampleHandlingDetails, SamplePreparationDetails, AnalysisDetails
ScreenResult SampleDetails
SignalToNoiseRatio SubstanceIdentificationDetails, InstrumentResponseDetails
StandardConcentration SubstanceIdentificationDetails
StandardFinalAmount SubstanceIdentificationDetails
StandardDeviationSubstanceIdentificationDetails, InstrumentResponseDetails, InstrumentResponseAdditionalDetails
WavelengthAnalysisDetails, SubstanceIdentificationDetails, InstrumentResponseDetails, InstrumentResponseAdditionalDetails
Yield AnalysisDetails
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Requirements for Environmental Electronic Data Delivery Submissions 35
APPENDIX C
Example CharacteristicsThe Type 2 DET allows laboratories to report any number of characteristics by using the Char-acteristicDetails data group. The following is a list of examples of optional characteristics that a laboratory should provide.
• Artifacts
• Boiling Point
• Clarity
• Color
• Column Diameter
• Column Length
• Conductance
• Density
• Melting Point
• Odor
• Percent Lipids
• Percent Moisture
• Percent Phase
• Percent Solids
• pH
• Refractive Index
• Temperature
• Texture
• Turbidity
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APPENDIX C
DET
Dat
a El
emen
t Defi
niti
ons
The
follo
win
g lis
t pro
vide
s de
finiti
ons,
the
inte
nded
repo
rtin
g fo
rmat
, and
cat
egor
izat
ion
for e
ach
data
ele
men
t with
in th
e Ty
pe 2
DET
.
Tabl
e 7.
TYP
E 2
DET
Dat
a El
emen
t Defi
niti
ons
Dat
a El
emen
tFo
rmat
Cat
egor
yB
usin
ess
Rul
eDefinitio
n
Agr
eem
ent
Mod
ifica
tion
Des
crip
tion
Text
Des
crip
tion
Te
xt th
at d
escr
ibes
any
mod
ifica
tions
mad
e to
the
labo
rato
ry’s
co
ntra
ct.
Agr
eem
ent
Mod
ifica
tion
Iden
tifier
Text
Des
crip
tion
A
clie
nt-d
efine
d id
entifi
er fo
r any
mod
ifica
tions
mad
e to
the
labo
rato
ry’s
con
tract
.
Agr
eem
entN
umbe
rTe
xtId
entifi
catio
n
A cl
ient
-defi
ned
cont
ract
num
ber t
hat s
peci
fies
the
cont
ract
or
agre
emen
t und
er w
hich
the
labo
rato
ry a
naly
zes
the
sam
ples
.
Ana
lysi
sBat
ch
Iden
tifier
Text
Ass
ocia
tion/
Gro
upin
g
A la
bora
tory
-defi
ned
iden
tifier
that
is u
sed
to li
nk m
ultip
le
anal
yses
don
e on
one
inst
rum
ent,
asso
ciat
ed w
ith o
ne o
r mor
e in
stru
men
t qua
lity
cont
rol s
ampl
es, a
t whi
ch th
e in
stru
men
t is
che
cked
to b
e in
con
trol a
t the
beg
inni
ng o
f an
anal
ysis
se
quen
ce.
Ana
lysi
sEnd
Dat
eD
ate
Dat
e
The
date
(and
tim
e, if
requ
ired)
of t
he e
nd o
f the
ana
lysi
s pe
riod,
if
the
sam
ple
aliq
uot o
r sta
ndar
d w
as a
naly
zed
over
a p
erio
d of
tim
e.
Ana
lysi
sSta
rtDat
eD
ate
Dat
e
The
date
(and
tim
e, if
requ
ired)
of a
naly
sis
of a
sam
ple
aliq
uot
or s
tand
ard.
If a
naly
zed
over
a ra
nge
of d
ates
, thi
s is
the
star
t da
te.
Ana
lysi
sTyp
eLi
mite
d Li
st
Cat
egor
izat
ion
A te
rm u
sed
to d
efine
the
type
of a
naly
sis
(e.g
., in
itial
, co
nfirm
atio
n, M
SA
). Th
is te
rm is
als
o us
ed to
uni
quel
y id
entif
y a
sing
le a
naly
sis
from
mul
tiple
ana
lyse
s th
at a
re u
sed
to g
ener
ate
a si
ngle
resu
lt.
Ana
lytic
alS
ervi
ce
Req
uest
Iden
tifier
Text
Iden
tifica
tion
A cl
ient
-defi
ned
num
ber o
r ide
ntifi
er th
at s
peic
ifies
the
serv
ice
requ
est.
CA
SR
egis
try
Num
ber
Text
Iden
tifica
tion
Th
e C
hem
ical
Abs
tract
Ser
vice
(CA
S) r
egis
try n
umbe
r for
a
subs
tanc
e.
Cha
ract
eris
ticN
ame
Text
Des
crip
tion
A
desc
riptiv
e te
rm u
sed
to id
entif
y th
e ch
arac
teris
tic b
eing
m
easu
red.
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Requirements for Environmental Electronic Data Delivery Submissions 37
APPENDIX C
Dat
a El
emen
tFo
rmat
Cat
egor
yB
usin
ess
Rul
eDefinitio
n
Cha
ract
eris
ticTy
peTe
xtC
ateg
oriz
atio
n
A te
rm th
at id
entifi
es th
e ty
pe o
f cha
ract
eris
tic b
eing
repo
rted.
Cha
ract
eris
ticU
nits
Lim
ited
List
C
ateg
oriz
atio
n
Uni
ts fo
r the
val
ue o
f a c
hara
cter
istic
.
Cha
ract
eris
ticVa
lue
Num
eric
or T
ext
A m
easu
red
or o
bser
ved
valu
e fo
r the
cha
ract
eris
tic b
eing
re
porte
d. T
he v
alue
can
eith
er b
e nu
mer
ic o
r tex
t bas
ed o
n th
e ch
arac
teris
tic b
eing
repo
rted.
Cle
anup
Bat
ch
Iden
tifier
Text
Ass
ocia
tion/
Gro
upin
g
A la
bora
tory
-defi
ned
iden
tifier
that
is u
sed
to li
nk m
ultip
le s
ampl
e al
iquo
ts th
at a
re c
lean
ed u
p to
geth
er fo
r pro
cess
ing
by o
ne
met
hod.
Cle
anup
Type
Lim
ited
List
C
ateg
oriz
atio
n
A te
rm th
at id
entifi
es th
e sp
ecifi
c cl
eanu
p pe
rform
ed w
hen
mul
tiple
opt
ions
are
giv
en w
ithin
the
refe
renc
ed m
etho
d.
Com
men
tTe
xtC
omm
ent
A
free-
form
rem
ark,
obs
erva
tion,
exp
lana
tion,
or e
xpan
sion
text
th
at c
an o
ccur
in a
ny p
aren
t dat
a el
emen
t.
Con
tact
Ele
ctro
nic
Add
ress
Text
Des
crip
tion
Th
e el
ectro
nic
addr
ess
(e-m
ail)
of th
e pe
rson
at t
he la
bora
tory
w
ho ta
kes
final
resp
onsi
bilit
y fo
r the
dat
a.
Con
tact
FullN
ame
Text
Des
crip
tion
Th
e pe
rson
at t
he la
bora
tory
who
take
s fin
al re
spon
sibi
lity
for
the
data
.
Con
tact
Iden
tifier
Text
Iden
tifica
tion
Iden
tifier
sha
ll be
use
d as
the
rela
tiona
l key
fo
r dat
a gr
oups
to
refe
renc
e a
parti
cula
r co
ntac
t.A
labo
rato
ry-d
efine
d un
ique
iden
tifier
for a
n in
divi
dual
with
in a
n or
gani
zatio
n.
Con
tact
Title
Text
Des
crip
tion
Th
e jo
b tit
le o
f the
per
son
at th
e la
bora
tory
who
take
s fin
al
resp
onsi
bilit
y fo
r the
dat
a.
Con
tact
Type
Lim
ited
List
C
ateg
oriz
atio
n
The
type
of t
he p
erso
n at
the
labo
rato
ry w
ho ta
kes
final
re
spon
sibi
lity
for t
he d
ata.
Dat
aPac
kage
Id
entifi
erTe
xtId
entifi
catio
n
A la
bora
tory
-defi
ned
iden
tifier
for t
his
data
del
iver
able
pac
kage
. Th
is id
entifi
er a
pplie
s to
a s
ingl
e de
liver
able
.
Dat
aPac
kage
Nam
eTe
xtD
escr
iptio
n
A la
bora
tory
-defi
ned
title
for t
his
data
del
iver
able
pac
kage
.
38 association of Public Health Laboratories
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38 association of Public Health Laboratories
APPENDIX C
Dat
a El
emen
tFo
rmat
Cat
egor
yB
usin
ess
Rul
eDefinitio
n
Dat
aPac
kage
Vers
ion
Text
Des
crip
tion
If
the
labo
rato
ry re
subm
its a
dat
a pa
ckag
e, th
is d
ata
elem
ent
dist
ingu
ishe
s be
twee
n th
e di
ffere
nt v
ersi
ons.
Dat
eFor
mat
Text
Des
crip
tion
A va
lue
that
spe
cifie
s th
e fo
rmat
of a
ll re
porte
d da
te/ti
me
valu
es
in a
n el
ectro
nic
data
del
iver
able
. Thi
s va
lue
can
inco
rpor
ate
the
time
zone
, if r
equi
red.
Exc
lusi
onIn
dica
tor
Boo
lean
Indi
cato
r/Boo
lean
Onl
y re
port
a va
lue
whe
n no
t in
clud
ed.
Indi
cate
s w
heth
er o
r not
this
item
is to
be
excl
uded
or e
valu
ated
as
par
t of t
his
data
pac
kage
.
Exp
ecte
dRes
ult
Text
Res
ult M
easu
rem
ent
The
expe
cted
or t
heor
etic
al re
sult
of a
sub
stan
ce th
at h
as b
een
spik
ed in
to a
sam
ple
aliq
uot o
r a s
tand
ard
at a
ny ti
me
durin
g th
e an
alys
is p
roce
ss.
Exp
ecte
dRes
ult
Uni
tsLi
mite
d Li
st
Res
ult M
easu
rem
ent
U
nits
for t
he e
xpec
ted
resu
lt.
Inst
rum
entId
entifi
erTe
xtId
entifi
catio
n
A la
bora
tory
-defi
ned
iden
tifier
for a
n in
stru
men
t.
Labo
rato
ryA
naly
sis
Iden
tifier
Text
Iden
tifica
tion
A la
bora
tory
-defi
ned
iden
tifier
for a
n an
alys
is th
at u
niqu
ely
iden
tifies
a s
ingl
e ru
n fo
r a s
ingl
e sa
mpl
e al
iquo
t or s
tand
ard.
Th
is id
entifi
er m
ust b
e un
ique
for a
t lea
st a
ll of
the
anal
yses
re
porte
d in
a s
ingl
e de
liver
able
, in
the
cont
ext o
f one
met
hod.
Labo
rato
ryFi
le
Iden
tifier
Text
Iden
tifica
tion
Th
e fil
e, a
nd p
ath
if re
quire
d, n
ame
whe
re th
e ra
w d
ata
from
the
anal
ysis
is s
tore
d in
the
labo
rato
ry.
Labo
rato
ryN
arra
tive
Text
Des
crip
tion
A la
bora
tory
text
ual a
ccou
nt th
at d
escr
ibes
any
app
ropr
iate
in
form
atio
n ab
out a
nom
alie
s th
at m
ay h
ave
occu
rred
dur
ing
the
anal
ysis
or r
evie
w o
f the
dat
a in
the
elec
troni
c da
ta d
eliv
erab
le.
Labo
rato
ry
Qua
lifier
sDefi
nitio
nTe
xtD
escr
iptio
n
A fo
rmal
sta
tem
ent o
f the
mea
ning
or s
igni
fican
ce o
f any
lab
qual
ifier
(s) r
epor
ted
by th
e la
bora
tory
.
Labo
rato
ryR
ecei
pt
Dat
eD
ate
Dat
e
The
date
(and
tim
e, if
requ
ired)
that
the
sam
ple
was
rece
ived
in
the
labo
rato
ry.
Labo
rato
ry
Rep
orte
dDat
eD
ate
Dat
e
The
date
(and
tim
e, if
requ
ired)
that
the
data
pac
kage
was
re
porte
d by
the
labo
rato
ry to
the
clie
nt.
X
Requirements for Environmental Electronic Data Delivery Submissions 39
APPENDIX C
Dat
a El
emen
tFo
rmat
Cat
egor
yB
usin
ess
Rul
eDefinitio
n
Labo
rato
ryR
esul
t Q
ualifi
erTe
xtD
escr
iptio
n
A la
bora
tory
-ass
igne
d st
ring
of re
sult
qual
ifier
s (u
sual
ly a
sin
gle
char
acte
r for
eac
h qu
alifi
er),
base
d on
clie
nt -d
efine
d ru
les
and
valu
es.
Labo
rato
ryS
ampl
e Id
entifi
erTe
xtId
entifi
catio
n
A la
bora
tory
-defi
ned
iden
tifier
that
uni
quel
y id
entifi
es a
sin
gle
sam
ple
that
is s
ubje
cted
to a
n an
alys
is. T
he L
abor
ator
y Id
entifi
er
shou
ld o
nly
be re
porte
d in
add
ition
to th
e S
ampl
e Id
entifi
er.
Labo
rato
ry
Sub
stan
ceId
entifi
erTe
xtId
entifi
catio
n
A la
bora
tory
-defi
ned
iden
tifier
for a
sub
stan
ce.
Loca
tionI
dent
ifier
Text
Iden
tifica
tion
A
clie
nt-d
efine
d id
entifi
er o
f the
sam
plin
g lo
catio
n at
a p
artic
ular
si
te.
Mea
sure
Nam
eTe
xtD
escr
iptio
n
Des
crib
es th
e m
easu
re b
eing
reco
rded
.
Mea
sure
Qua
lifier
C
ode
Text
Des
crip
tion
A
code
use
d to
iden
tify
any
qual
ifyin
g is
sues
that
affe
ct th
e re
sults
.
Mea
sure
Uni
tCod
eLi
mite
d Li
st
Cat
egor
izat
ion
Th
e co
de th
at re
pres
ents
the
unit
for m
easu
ring
the
item
.
Mea
sure
Valu
eTe
xtD
escr
iptio
n
The
reco
rded
dim
ensi
on, c
apac
ity, q
ualit
y, o
r am
ount
of
som
ethi
ng a
scer
tain
ed b
y m
easu
ring
or o
bser
ving
.
Met
hodC
ateg
ory
Lim
ited
List
C
ateg
oriz
atio
n
The
gene
ral c
lass
or c
omm
on n
ame
for t
he g
roup
of s
ubst
ance
s be
ing
mea
sure
d by
a g
iven
met
hod
for t
he s
ampl
e.
Met
hodC
odeT
ype
Lim
ited
List
C
ateg
oriz
atio
n
The
publ
ishe
d re
fere
nce
code
of t
he m
etho
d us
ed b
y th
e la
bora
tory
to a
naly
ze th
e sa
mpl
e.
Met
hodD
escr
iptio
nTe
xtD
escr
iptio
n
A br
ief s
umm
ary
that
pro
vide
s ge
nera
l des
crip
tive
info
rmat
ion
abou
t the
met
hod.
Met
hodI
dent
ifier
Text
Iden
tifica
tion
Rep
ort t
he
Web
ED
R
Met
hod
Iden
tifier
list
ed
on th
e M
etho
d P
rofil
e.
The
publ
ishe
d, u
niqu
e id
entifi
er (u
sual
ly c
onsi
stin
g of
num
bers
or
a c
ombi
natio
n of
lette
rs a
nd n
umbe
rs) f
or th
e m
etho
d us
ed b
y th
e la
bora
tory
to a
naly
ze th
e sa
mpl
e.
Met
hodL
evel
Text
Des
crip
tion
The
appr
oxim
ate
leve
l of s
ubst
ance
s in
the
sam
ple,
usu
ally
sp
ecifi
ed in
clie
nt-d
efine
d co
ncen
tratio
n ra
nges
and
det
erm
ined
vi
a a
scre
enin
g pr
oced
ure.
40 association of Public Health Laboratories
X X
40 association of Public Health Laboratories
APPENDIX C
Dat
a El
emen
tFo
rmat
Cat
egor
yB
usin
ess
Rul
eDefinitio
n
Met
hodM
odifi
catio
n D
escr
iptio
nTe
xtD
escr
iptio
n
Text
that
iden
tifies
any
mod
ifica
tions
mad
e to
the
publ
ishe
d re
fere
nce
met
hod.
Met
hodM
odifi
catio
n Id
entifi
erTe
xtId
entifi
catio
n
A cl
ient
-defi
ned
iden
tifier
that
iden
tifies
mod
ifica
tions
mad
e to
th
e pu
blis
hed
refe
renc
e m
etho
d.
Met
hodN
ame
Text
Des
crip
tion
Th
e pu
blis
hed
nam
e or
title
of t
he m
etho
d us
ed b
y th
e la
bora
tory
to a
naly
ze th
e sa
mpl
e.
Met
hodS
ourc
e N
ame
Text
Des
crip
tion
The
auth
or o
r pub
lishi
ng a
genc
y of
the
met
hod
used
by
the
labo
rato
ry to
ana
lyze
the
sam
ple.
Met
hodT
ype
Lim
ited
List
C
ateg
oriz
atio
n
Labo
rato
ries
mus
t alw
ays
repo
rt th
e C
lient
met
hod,
al
l oth
er
met
hods
are
op
tiona
l. A
term
that
iden
tifies
the
tech
nolo
gy o
r met
hod
clas
sific
atio
n of
th
e m
etho
d us
ed b
y th
e la
bora
tory
to a
naly
ze th
e sa
mpl
e.
Met
hodV
ersi
onTe
xtD
escr
iptio
n
The
vers
ion
or re
visi
on o
f the
met
hod
used
by
the
labo
rato
ry to
an
alyz
e th
e sa
mpl
e.
Org
aniz
atio
n Id
entifi
erTe
xtId
entifi
catio
n
The
iden
tifier
ass
ocia
ted
with
an
orga
niza
tion
(e.g
., la
bora
tory
, cl
ient
, sub
cont
ract
or, e
tc.)
perfo
rmin
g a
spec
ific
role
in c
onte
xt o
f th
e pr
ojec
t.
Org
aniz
atio
n Lo
catio
nAdd
ress
Text
Des
crip
tion
Th
e pr
imar
y st
reet
add
ress
of t
he lo
catio
n of
the
labo
rato
ry
perfo
rmin
g th
is a
naly
sis.
Org
aniz
atio
n Lo
catio
nAdd
ress
City
Text
Des
crip
tion
Th
e ci
ty in
whi
ch th
e la
bora
tory
per
form
ing
the
anal
ysis
is
loca
ted.
Org
aniz
atio
n Lo
catio
nAdd
ress
C
ount
ryTe
xtD
escr
iptio
n
The
coun
try in
whi
ch th
e la
bora
tory
per
form
ing
the
anal
ysis
is
loca
ted.
Org
aniz
atio
n Lo
catio
nAdd
ress
S
tate
Text
Des
crip
tion
Th
e st
ate
in w
hich
the
labo
rato
ry p
erfo
rmin
g th
e an
alys
is is
lo
cate
d.
X
Requirements for Environmental Electronic Data Delivery Submissions 41
APPENDIX C
Dat
a El
emen
tFo
rmat
Cat
egor
yB
usin
ess
Rul
eDefinitio
n
Org
aniz
atio
n Lo
catio
nAdd
ress
Zi
pCod
eTe
xtD
escr
iptio
n
The
ZIP
or p
osta
l cod
e of
the
labo
rato
ry p
erfo
rmin
g th
e an
alys
is.
Org
aniz
atio
nMai
ling
Add
ress
Text
Des
crip
tion
The
seco
ndar
y ad
dres
s of
the
labo
rato
ry p
erfo
rmin
g th
is
anal
ysis
, if a
pplic
able
. Thi
s w
ould
incl
ude
addi
tiona
l add
ress
in
form
atio
n (e
.g.,
suite
, mai
ldro
p, e
tc.).
Org
aniz
atio
nNam
eTe
xtD
escr
iptio
n
The
nam
e of
an
orga
niza
tion
(e.g
., la
bora
tory
, clie
nt,
subc
ontra
ctor
, etc
.) pe
rform
ing
a sp
ecifi
c ro
le in
con
text
of t
he
proj
ect.
Org
aniz
atio
n Te
leph
oneN
umbe
rTe
xtD
escr
iptio
n
The
10-d
igit
tele
phon
e nu
mbe
r of t
he la
bora
tory
per
form
ing
the
anal
ysis
.
Org
aniz
atio
nTyp
eTe
xtC
ateg
oriz
atio
n
The
role
of t
he o
rgan
izat
ion
in c
onte
xt o
f the
pro
ject
.
Pre
para
tionB
atch
Id
entifi
erTe
xtA
ssoc
iatio
n/G
roup
ing
A la
bora
tory
-defi
ned
iden
tifier
that
is u
sed
to li
nk m
ultip
le s
ampl
e al
iquo
ts th
at a
re p
repa
red
toge
ther
for a
naly
sis
by o
ne m
etho
d.
“Tog
ethe
r” im
plie
s si
mila
rity
of ti
me,
pla
ce, a
nd m
anne
r of
prep
arat
ion.
Pre
para
tionE
nd
Dat
eD
ate
Dat
e
The
date
(and
tim
es, i
f req
uire
d) o
f the
end
of t
he p
repa
ratio
n pe
riod
for t
he s
ampl
e al
iquo
t, if
the
sam
ple
was
pre
pare
d ov
er a
pe
riod
of ti
me.
Pre
para
tionS
tart
Dat
eD
ate
Dat
e
The
date
(and
tim
e, if
requ
ired)
of t
he p
repa
ratio
n of
this
sam
ple
aliq
uot.
Pre
para
tion
is u
sed
gene
rally
to in
clud
e m
etho
d sp
ecifi
c te
chni
ques
suc
h as
ext
ract
ion,
dig
estio
n, a
nd s
epar
atio
n. If
pr
epar
ed o
ver a
rang
e of
dat
es, t
his
is th
e st
art d
ate.
Pre
para
tionT
ype
Lim
ited
List
C
ateg
oriz
atio
n
A cl
ient
-defi
ned
desc
riptio
n us
ed to
defi
ne th
e sp
ecifi
c pr
epar
atio
n pe
rform
ed w
hen
mul
tiple
opt
ions
are
giv
en w
ithin
th
e re
fere
nced
met
hod.
Pre
serv
ativ
eTe
xtD
escr
iptio
n
The
chem
ical
com
poun
d th
at w
as a
dded
to th
e sa
mpl
e to
pr
otec
t aga
inst
dec
ay o
r dec
ompo
sitio
n.
Pro
ject
Iden
tifier
Text
Iden
tifica
tion
A cl
ient
-defi
ned
iden
tifier
for a
pro
ject
repo
rting
a p
artic
ular
set
of
dat
a. T
ypic
ally,
a p
roje
ct c
onsi
sts
of s
ampl
es fr
om o
ne s
ite
colle
cted
ove
r som
e de
fined
per
iod
of ti
me.
Pro
ject
Nam
eTe
xtD
escr
iptio
n
A de
scrip
tive
nam
e or
labe
l for
the
proj
ect f
or w
hich
dat
a is
be
ing
repo
rted
for
42 association of Public Health Laboratories
X X
42 association of Public Health Laboratories
APPENDIX C
Dat
a El
emen
tFo
rmat
Cat
egor
yB
usin
ess
Rul
eDefinitio
n
Rep
ortin
gLim
itTe
xtD
escr
iptio
n
The
repo
rting
lim
it of
the
subs
tanc
e be
ing
mea
sure
d. R
epor
ting
limits
are
defi
ned
in te
rms
of a
num
ber b
elow
whi
ch d
ata
is
typi
cally
repo
rted
as ‘n
ot d
etec
ted’
for t
he s
ubst
ance
bei
ng
mea
sure
d.
Rep
ortin
gLim
itTyp
eLi
mite
d Li
st
Cat
egor
izat
ion
A
term
that
iden
tifies
how
the
repo
rting
lim
it w
as d
eter
min
ed o
r re
porte
d.
Rep
ortin
gLim
it U
nits
Lim
ited
List
C
ateg
oriz
atio
n
Uni
ts fo
r the
repo
rting
lim
it.
Res
ult
Text
Res
ult M
easu
rem
ent
Th
e fin
al c
alcu
late
d re
sult
for a
sub
stan
ce a
ccou
ntin
g fo
r all
sam
ple
aliq
uot a
mou
nts,
dilu
tions
, moi
stur
e de
term
inat
ions
, etc
Res
ultB
asis
Text
Des
crip
tion
Th
e ba
sis
upon
whi
ch th
e fin
al re
sults
wer
e ca
lcul
ated
.
Res
ultU
ncer
tain
tyN
umer
icR
esul
t Mea
sure
men
t
The
estim
ated
am
ount
, exp
ress
ed a
s a
sym
met
ric in
terv
al
cent
ered
on
the
Res
ult,
by w
hich
the
Res
ult m
ay d
iffer
from
the
true
valu
e du
e to
all
effe
cts
rela
ted
to a
naly
sis
of th
e sa
mpl
e al
iquo
t by
the
labo
rato
ry.
Res
ultU
nits
Lim
ited
List
R
esul
t Mea
sure
men
t
Uni
ts fo
r the
resu
lt.
Run
Bat
chId
entifi
erTe
xtA
ssoc
iatio
n/G
roup
ing
A la
bora
tory
-defi
ned
iden
tifier
that
is u
sed
to li
nk m
ultip
le
anal
yses
per
form
ed o
n on
e in
stru
men
t and
und
er th
e co
ntro
l of
one
initi
al c
alib
ratio
n.
Sam
pleC
hain
of
Cus
tody
Iden
tifier
Text
Iden
tifica
tion
A cl
ient
-defi
ned
iden
tifier
for t
he c
hain
of c
usto
dy d
ocum
ent a
nd/
or tr
acki
ng re
cord
ass
ocia
ted
with
rece
ipt o
f thi
s sa
mpl
e in
the
labo
rato
ry.
Sam
pleC
olle
ctio
n E
ndD
ate
Dat
eD
ate
The
date
(and
tim
e, if
requ
ired)
, of t
he e
nd o
f the
sam
ple
colle
ctio
n pe
riod,
if th
e sa
mpl
e w
as c
olle
cted
ove
r a p
erio
d of
tim
e.
Sam
pleC
olle
ctio
n S
tartD
ate
Dat
eD
ate
The
date
(and
tim
e, if
requ
ired)
the
sam
ple
was
col
lect
ed. I
f th
e sa
mpl
e w
as c
olle
cted
ove
r a ra
nge
of d
ates
, thi
s is
the
star
t da
te.
Sam
pleD
ataG
roup
Ty
peLi
mite
d Li
st
Cat
egor
izat
ion
W
heth
er o
r not
the
data
in th
is n
ode
is re
late
d to
a p
repa
ratio
n or
cle
anup
act
ivity
.
X
Requirements for Environmental Electronic Data Delivery Submissions 43
APPENDIX C
Dat
a El
emen
tFo
rmat
Cat
egor
yB
usin
ess
Rul
eDefinitio
n
Sam
pleI
dent
ifier
Text
Iden
tifica
tion
Rep
ort c
lient
id
entifi
er fo
r fie
ld g
ener
ated
sa
mpl
es a
nd
labo
rato
ry
iden
tifier
for
labo
rato
ry o
r in
stru
men
t sa
mpl
es.
A un
ique
iden
tifier
ass
igne
d to
a s
ampl
e. T
his
iden
tifier
sho
uld
be w
hat i
s as
sign
ed to
the
sam
ple
by th
e cl
ient
. Thi
s el
emen
t sh
ould
alw
ays
be re
porte
d. If
repo
rting
a la
bora
tory
gen
erat
ed
sam
ple
then
repo
rt th
e la
bora
torie
s un
ique
iden
tifier
for t
he
sam
ple.
Sam
pleM
atrix
Lim
ited
List
C
ateg
oriz
atio
n
An
iden
tifier
of t
he g
ener
al s
ampl
e su
bstra
te o
r med
ia.
Sam
pleT
ype
Lim
ited
List
C
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APPENDIX C
DET Valid ValuesThe following list details the values to which certain fields are limited within the DET. Valid values help ensure that automated processing can occur by providing a common language for important fields. Laboratories should only report a value in this list when reporting infor-mation for the data element that has a valid value list. Laboratories should use SEDD’s valid value list as a reference for all valid values.
Table 8 DET Valid Values
Field Valid Value
Analysis Type Initial_Calibration, Average, MSA, Detection_Limit, Initial, Confirmation, Final
Organization Type Customer, Laboratory, Sampler
Sample Data Group Type Preparation, Cleanup
Exclusion Indicator NO
Reporting Limit TypeCRRL, MDL, MDL_sa, IDL, LOD, LOD_sa, Ld, Ld_sa, ML, ML_sa, MRL, MRL_sa, Lc, Lc_sa, LCMRL, LCMRL_sa, LOQ, LOQ_sa, Lq, Lq_sa, PQL, PQL_sa, EQL, EQL_sa
Substance TypeTarget, Spike, TIC, Internal_Standard, Surrogate, System_Monitoring_Compound, Monitor, Tracer, Instrument_Performance, Deuterated_Monitoring_Compound
Method Type Client, Laboratory, Reference
SampleType
Cleanup_Blank, Duplicate, Field_Blank, Field_Duplicate, Field_Reagent_Blank, Field_Sample, Instrument_Blank, Laboratory_Control_Sample, Laboratory_Control_Sample_Duplicate, Laboratory_Duplicate, Laboratory_Fortified_Blank, Laboratory_Fortified_Blank_Duplicate, Laboratory_Fortified_Sample_Matrix, Laboratory_Fortified_Sample_Matrix_Duplicate, Laboratory_Performance_Check, Laboratory_Reagent_Blank, Matrix_Spike, Matrix_Spike_Duplicate, Matrix_Spiking_Solution, Method_Blank, Method_Instrument_Blank, Non-client_Sample, Performance_Evaluation_Sample, Post_Digestion_Spike, PT_Sample, Reagent_Blank, Serial_Dilution, Split_Samples, Storage_Blank, Storage_Blank, Trip_Blank, Baseline, Continuing_Calibration, Continuing_Calibration_Blank, Continuing_Calibration_Verification, Detection_Limit_Check_Standard, Florisil_Cartridge_Check, GPC_Calibration_Check, Initial_Calibration, Initial_Calibration_Blank, Initial_Calibration_Verification, Instrument_Performance_Check_PEM, Instrument_Performance_Check_Resolution, Instrument_Performance_Check_Tune, Interanalyte_Correction_Factor, Interference_Check_Standard_A, Interference_Check_Standard_A/B, Linear_Range_Verification, Quantitation_Limit_Check_Standard, ReslopeResolution_Check, Standard_Reference_Material, Calibration_Blank, Calibration_Standard, Continuing_Calibration_Check_Standard, Continuing_Calibration_Verification_Standard, End_Calibration_Check_Standard, Initial_Calibration_Check_Standard, Initial_Calibration_Standards, Instrument_Performance_Check_Solution, Tuning_Solution
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APPENDIX D
Appendix D: XML Reporting GuideThe Data Exchange Template (DET) specifies the data necessary to include in an electronic submission, and XML is the format in which Type 2 will be provided. The following guide pro-vides an overview of how the XML can be used to report a Type 2 electronic submission.
XML Syntax GuidelinesXML files must follow a specific structure and syntax so that other systems can read the con-tents. The following list provides general syntax rules that must be followed by every XML file:
• Non-empty elements are delimited by both a start-tag and an end-tag. (http://www.aphl.org/aphlprograms/eh/chemicals/drinkwater/Documents/EH_2010Jan_EPA_ERLNDataSubmissionsReq.pdf)
• Empty data elements can be reported, and if so, shall be indicated by a single tag indicating the data element name followed by a space and a forward slash and surrounded by angled brackets. Example: <SiteID />
• It is preferred that empty elements, for all but the required data elements, be left out of the file entirely so that only elements with data are reported. Required data elements must have values.
• Spaces are not allowed between opening and closing tags unless they are part of the data being reported for the element.
• Data element names are case-sensitive and shall be reported as described in the DET.
• Blank lines are allowed and can occur anywhere in the XML document. Blank lines can greatly improve the human readability factor of an XML file by providing visual separations in the data.
• Comment lines can occur anywhere in the XML document and are used to annotate the XML for human readers. Comment lines are usually displayed and printed by XML readers as they are not considered part of the data in the file. Comment lines are defined by angled brackets with the content surrounded by an exclamation mark and two dashes. Example: <!—Content is for samples from Site 1-->
• Data group and data elements names must exist in the DTD. Laboratories can report more data than required for a Type 2 data submission but the element must exist in the DTD and be reported in the correct data group. Laboratories cannot add new data groups or data elements to an XML document.
• Data elements cannot appear more than once within the same data group.
• The Type 2 DTD defines a particular order in which fields can be reported. XML files can have fewer fields than the DTD, but they must still appear in the same order. For example, in the SampleDetails data group the SampleIdentifier element is listed above the SampleMatrix element. This means that any Type 2 XML file that reports
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APPENDIX D
SampleIdentifier and SampleMatrix must report them in this same order.
• The occurrence of a data group and/or data element within a DTD as well as the absence of a value can be defined in a DTD using XML syntax. The following is a list of syntax used throughout the Type 2 DTD to define how many times a data group can be reported as well as if a data element requires a value or if a value is optional.
• ? data element or data group is not required and may only appear once under the parent data group that uses this reference. Example: Under the SampleDetails data group the SampleChainofCustodyIdenifier appears with a ? after it. This means this element does not have to be reported for this group but if it is, it can only appear once under the SampleDetails group.
• * data element or data group is not required and may appear zero or more times under the parent data group that uses this reference. Example: The OrganizationDetails group defines its relationship with the PointofContacts group with an * meaning one organization can have 0 or more contacts reported under it.
• + data element or data group is required and can appear more than one time under the parent data group that uses this reference. Example: The ProjectDetails group defines its relationship with the SampleDetails group with a + meaning the Project must have at least one sample reported but can have more than one.
• No syntax after an element (Ex. SampleIdentifier,) – data element is required, must contain a value, and can only appear once under the parent data group that uses this reference.
Type 2 Data Hierarchy for ReportingThe Type 2 DET defines the data groups that organize the individual elements into group-ings which in turn define the data. These groupings have inherent relationships and must be reported in a certain order to maintain the relationship in the XML document. The Type 2 DET uses a hierarchical relationship between most data groups, with the exception of Contact Information which has a relational relationship to several data groups. A hierarchical rela-tionship means the placement of the data groups and data elements in the XML document defines the relationship of the content. A ‘relational’ relationship provides the ability to refer-ence another data group by providing some form of an identifier, similar to how foreign keys in a database table function. Refer to Appendix C: Data Exchange Template (DET) for Type 2 for additional information regarding these groups.
In a DTD that primarily uses hierarchical relationships, there is a defined order in which data groups can be reported in a file. The following depicts the order in which data groups must be reported in a Type 2 XML document. The data groups that appear as subs to the primary level can be reported in any order as long as they are under their associated data group.
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APPENDIX D
Type 2 Data Group Reporting Hierarchy:
1. ProjectDetails
2. OrganizationDetailsa. PointOfContactDetails
3. MethodDetails
4. SampleDetailsa. AnalysisDetails
i. SamplePreparationDetailsii. SubstanceIdentificationDetails
1. MeasureDetailsb. CharacteristicDetails
Type 2 DTD Required Data ElementsThe Type 2 DTD has defined a minimum list of required data elements based on the Type 1 requirements. By defining required fields in the DTD, Type 2 can ensure that data submitted contains the minimum amount of information necessary to identify the submission before the file is processed. Required elements are defined in the DTD by the lack of a character following a data element (Example: SampleIdentifier). The following is a list of the Type 2 DTD required fields. Note that a value must be present in every instance of these fields in order for a submission to successfully be uploaded into WebEDR, a free, web-based EPA data review package.
Table 9 DTD Required Data Groups
TYPE 2 Data Group TYPE 2 Data Element
ProjectDetails AnalyticalServiceRequestIdentifier
ProjectDetails DataPackageIdentifier
ProjectDetails ProjectIdentifier
OrganizationDetails OrganizationIdentifier
SampleDetails SampleIdentifier
SampleDetails SampleMatrix
AnalysisDetails MethodIdentifier
SubstanceIdentification Details SubstanceName
MethodDetails MethodIdentifier
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APPENDIX D
The Type 2 DTD also defines required data elements when reporting optional data groups. The following list defines the conditionally required data elements for the Type 2 DTD.
Table 10 DTD Conditionally Required Data Groups
TYPE 2 Data Group TYPE 2 Data Element
PointofContactDetails ContactIdentifier
CharacteristicDetails CharacteristicName
CharacteristicDetails CharacteristicValue
MeasureDetails MeasureName
MeasureDetails MeasureValue
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APPENDIX E
Appendix E: Type 2 Document Type Definition (DTD)An XML DTD defines the building blocks of an XML document and is the most common way to specify an XML document. It defines the document structure with a list of legal elements and attributes. A DTD defines the structure of the XML document and validates the correctness of a file by providing the acceptable values for the document. The DTD provides laboratories with what their XML documents will be validated against and describes what should be reported.
The ERLN DTD is available electronically on the APHL website.
<?xml version=”1.0” encoding=”UTF-8”?>
<!--ERLN_General_1.DTD 07/07/2009-->
<!ELEMENT ProjectDetails (
AgreementModificationDescription?, AgreementModificationIdentifier?, AgreementNumber?, AnalyticalServiceRequestIdentifier, Comment?, DataPackageIdentifier, DataPackageName?, DataPackageVersion?, DateFormat?, LaboratoryNarrative?, LaboratoryQualifiersDefinition?, LaboratoryReportedDate?, ProjectIdentifier, ProjectName?, MethodDetails+, OrganizationDetails+, SampleDetails+ )><!ELEMENT MethodDetails ( Comment?, MethodCategory?, MethodCodeType?, MethodDescription?, MethodIdentifier, MethodLevel?, MethodModificationDescription?, MethodModificationIdentifier?, MethodName?, MethodSourceName?, MethodType?,
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APPENDIX E
MethodVersion? )><!ELEMENT OrganizationDetails ( Comment?, OrganizationIdentifier, OrganizationLocationAddress?, OrganizationLocationAddressCity?, OrganizationLocationAddressCountry?, OrganizationLocationAddressState?, OrganizationLocationAddressZipCode?, OrganizationMailingAddress?, OrganizationName?, OrganizationTelephoneNumber*, OrganizationType?, PointofContactDetails* )><!ELEMENT PointofContactDetails ( Comment?, ContactElectronicAddress?, ContactFullName?, ContactIdentifier, ContactTitle?, ContactType? )><!ELEMENT SampleDetails ( ContactIdentifier*, LaboratoryReceiptDate?, LaboratorySampleIdentifier?, LocationIdentifier?, Preservative?, SampleChainofCustodyIdentifier?, SampleCollectionEndDate?, SampleCollectionStartDate?, SampleIdentifier, SampleMatrix, SampleType?, StorageBatchIdentifier?, AnalysisDetails+, CharacteristicDetails* )><!ELEMENT AnalysisDetails ( AnalysisBatchIdentifier?, AnalysisEndDate?, AnalysisStartDate?,
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APPENDIX E
AnalysisType?, ContactIdentifier*, InstrumentIdentifier?, LaboratoryAnalysisIdentifier?, LaboratoryFileIdentifier?, MethodIdentifier, PreparationBatchIdentifier?, ResultBasis?, RunBatchIdentifier?, SamplePreparationDetails*, SubstanceIdentificationDetails+ )><!ELEMENT SamplePreparationDetails ( CleanupBatchIdentifier?, CleanupType?, ContactIdentifier*, MethodIdentifier?, PreparationEndDate?, PreparationStartDate?, SampleDataGroupType? )><!ELEMENT SubstanceIdentificationDetails ( CASRegistryNumber?, ExclusionIndicator?, ExpectedResult?, ExpectedResultUnits?, LaboratoryResultQualifier?, LaboratorySubstanceIdentifier?, ReportingLimit?, ReportingLimitType?, ReportingLimitUnits?, Result?, ResultUncertainty?, ResultUnits?, SubstanceName, SubstanceType?, MeasureDetails* )><!ELEMENT CharacteristicDetails ( CharacteristicName, CharacteristicType?, CharacteristicUnits?, CharacteristicValue, Comment?
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APPENDIX E
)><!ELEMENT MeasureDetails ( MeasureName, MeasureQualifierCode?, MeasureUnitCode?, MeasureValue )><!ELEMENT AgreementModificationDescription (#PCDATA)><!ELEMENT AgreementModificationIdentifier (#PCDATA)><!ELEMENT AgreementNumber (#PCDATA)><!ELEMENT AnalysisBatchIdentifier (#PCDATA)><!ELEMENT AnalysisEndDate (#PCDATA)><!ELEMENT AnalysisStartDate (#PCDATA)><!ELEMENT AnalysisType (#PCDATA)><!ELEMENT AnalyticalServiceRequestIdentifier (#PCDATA)><!ELEMENT CASRegistryNumber (#PCDATA)><!ELEMENT CharacteristicName (#PCDATA)><!ELEMENT CharacteristicType (#PCDATA)><!ELEMENT CharacteristicUnits (#PCDATA)><!ELEMENT CharacteristicValue (#PCDATA)><!ELEMENT CleanupBatchIdentifier (#PCDATA)><!ELEMENT CleanupType (#PCDATA)><!ELEMENT Comment (#PCDATA)><!ELEMENT ContactElectronicAddress (#PCDATA)><!ELEMENT ContactFullName (#PCDATA)><!ELEMENT ContactIdentifier (#PCDATA)><!ELEMENT ContactTitle (#PCDATA)><!ELEMENT ContactType (#PCDATA)><!ELEMENT DataPackageIdentifier (#PCDATA)><!ELEMENT DataPackageName (#PCDATA)><!ELEMENT DataPackageVersion (#PCDATA)><!ELEMENT DateFormat (#PCDATA)><!ELEMENT ExclusionIndicator (#PCDATA)><!ELEMENT ExpectedResult (#PCDATA)><!ELEMENT ExpectedResultUnits (#PCDATA)><!ELEMENT InstrumentIdentifier (#PCDATA)><!ELEMENT LaboratoryAnalysisIdentifier (#PCDATA)><!ELEMENT LaboratoryFileIdentifier (#PCDATA)><!ELEMENT LaboratoryNarrative (#PCDATA)><!ELEMENT LaboratoryQualifiersDefinition (#PCDATA)><!ELEMENT LaboratoryReceiptDate (#PCDATA)><!ELEMENT LaboratoryReportedDate (#PCDATA)><!ELEMENT LaboratoryResultQualifier (#PCDATA)><!ELEMENT LaboratorySampleIdentifier (#PCDATA)>
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APPENDIX E
<!ELEMENT LaboratorySubstanceIdentifier (#PCDATA)><!ELEMENT LocationIdentifier (#PCDATA)><!ELEMENT MeasureName (#PCDATA)><!ELEMENT MeasureQualifierCode (#PCDATA)><!ELEMENT MeasureUnitCode (#PCDATA)><!ELEMENT MeasureValue (#PCDATA)><!ELEMENT MethodCategory (#PCDATA)><!ELEMENT MethodCodeType (#PCDATA)><!ELEMENT MethodDescription (#PCDATA)><!ELEMENT MethodIdentifier (#PCDATA)><!ELEMENT MethodLevel (#PCDATA)><!ELEMENT MethodModificationDescription (#PCDATA)><!ELEMENT MethodModificationIdentifier (#PCDATA)><!ELEMENT MethodName (#PCDATA)><!ELEMENT MethodSourceName (#PCDATA)><!ELEMENT MethodType (#PCDATA)><!ELEMENT MethodVersion (#PCDATA)><!ELEMENT OrganizationIdentifier (#PCDATA)><!ELEMENT OrganizationLocationAddress (#PCDATA)><!ELEMENT OrganizationLocationAddressCity (#PCDATA)><!ELEMENT OrganizationLocationAddressCountry (#PCDATA)><!ELEMENT OrganizationLocationAddressState (#PCDATA)><!ELEMENT OrganizationLocationAddressZipCode (#PCDATA)><!ELEMENT OrganizationMailingAddress (#PCDATA)><!ELEMENT OrganizationName (#PCDATA)><!ELEMENT OrganizationTelephoneNumber (#PCDATA)><!ELEMENT OrganizationType (#PCDATA)><!ELEMENT PreparationBatchIdentifier (#PCDATA)><!ELEMENT PreparationEndDate (#PCDATA)><!ELEMENT PreparationStartDate (#PCDATA)><!ELEMENT Preservative (#PCDATA)><!ELEMENT ProjectIdentifier (#PCDATA)><!ELEMENT ProjectName (#PCDATA)><!ELEMENT ReportingLimit (#PCDATA)><!ELEMENT ReportingLimitType (#PCDATA)><!ELEMENT ReportingLimitUnits (#PCDATA)><!ELEMENT Result (#PCDATA)><!ELEMENT ResultBasis (#PCDATA)><!ELEMENT ResultUncertainty (#PCDATA)><!ELEMENT ResultUnits (#PCDATA)><!ELEMENT RunBatchIdentifier (#PCDATA)><!ELEMENT SampleChainofCustodyIdentifier (#PCDATA)><!ELEMENT SampleCollectionEndDate (#PCDATA)><!ELEMENT SampleCollectionStartDate (#PCDATA)>
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<!ELEMENT SampleDataGroupType (#PCDATA)><!ELEMENT SampleIdentifier (#PCDATA)><!ELEMENT SampleMatrix (#PCDATA)><!ELEMENT SampleType (#PCDATA)><!ELEMENT StorageBatchIdentifier (#PCDATA)><!ELEMENT SubstanceName (#PCDATA)><!ELEMENT SubstanceType (#PCDATA)>
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